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Trial record 1 of 1 for:    3066K1-2217
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Study Evaluating The Safety, Efficacy & Pharmacokinetics Of Temsirolimus(CCI-779) In Subjects With Advanced Renal Cell Carcinoma

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ClinicalTrials.gov Identifier: NCT00494091
Recruitment Status : Completed
First Posted : June 29, 2007
Results First Posted : July 9, 2012
Last Update Posted : March 21, 2013
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Advanced Renal Cell Carcinoma
Intervention Drug: Temsirolimus (CCI-779)
Enrollment 82
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Temsirolimus 20 mg/m^2 Temsirolimus 25 mg
Hide Arm/Group Description Temsirolimus 20 milligrams per square meter (mg/m^2) intravenously (IV) once weekly until disease progression, unacceptable toxicity, or withdrawal of consent. Temsirolimus 25 mg IV once weekly until disease progression, unacceptable toxicity, or withdrawal of consent.
Period Title: Overall Study
Started 6 76
Completed 0 0
Not Completed 6 76
Reason Not Completed
Death             5             54
Lost to Follow-up             0             4
Other             1             11
Withdrawal by Subject             0             7
Arm/Group Title Temsirolimus 20 mg/m^2 Temsirolimus 25 mg Total
Hide Arm/Group Description Temsirolimus 20 milligrams per square meter (mg/m^2) intravenously (IV) once weekly until disease progression, unacceptable toxicity, or withdrawal of consent. Temsirolimus 25 mg IV once weekly until disease progression, unacceptable toxicity, or withdrawal of consent. Total of all reporting groups
Overall Number of Baseline Participants 6 76 82
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 6 participants 76 participants 82 participants
59.67  (10.29) 55.20  (11.52) 55.52  (11.43)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 76 participants 82 participants
Female
0
   0.0%
23
  30.3%
23
  28.0%
Male
6
 100.0%
53
  69.7%
59
  72.0%
1.Primary Outcome
Title Percentage of Participants With Clinical Benefit
Hide Description Clinical benefit: confirmed complete response (CR) or partial response (PR) or had stable disease (SD) lasting at least 24 weeks. CR was the disappearance of all target lesions and nontarget lesions. PR was at least a 30 percent (%) decrease in sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. SD was having neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD).
Time Frame Baseline Up to 4 years
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) population included all participants who were enrolled in this study.
Arm/Group Title Temsirolimus 20 mg/m^2 Temsirolimus 25 mg
Hide Arm/Group Description:
Temsirolimus 20 milligrams per square meter (mg/m^2) intravenously (IV) once weekly until disease progression, unacceptable toxicity, or withdrawal of consent.
Temsirolimus 25 mg IV once weekly until disease progression, unacceptable toxicity, or withdrawal of consent.
Overall Number of Participants Analyzed 6 76
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
50.0
(11.8 to 88.2)
48.7
(37.0 to 60.4)
2.Secondary Outcome
Title Progression-free Survival (PFS)
Hide Description Median time from the date of enrollment to the first documentation of objective tumor progression or to death due to any cause, whichever occurs first.
Time Frame Baseline Up to 4 years
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who were enrolled in this study.
Arm/Group Title Temsirolimus 20 mg/m^2 Temsirolimus 25 mg
Hide Arm/Group Description:
Temsirolimus 20 milligrams per square meter (mg/m^2) intravenously (IV) once weekly until disease progression, unacceptable toxicity, or withdrawal of consent.
Temsirolimus 25 mg IV once weekly until disease progression, unacceptable toxicity, or withdrawal of consent.
Overall Number of Participants Analyzed 6 76
Median (95% Confidence Interval)
Unit of Measure: months
8.7
(4.0 to 29.0)
7.3
(3.8 to 9.9)
3.Secondary Outcome
Title Percentage of Participants With Objective Response
Hide Description Percentage of participants with objective response based assessment of confirmed CR or confirmed PR according to Response Evaluation Criteria In Solid Tumors (RECIST). CR is disappearance of all target lesions. PR shows at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.
Time Frame Baseline Up to 4 years
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who were enrolled in this study.
Arm/Group Title Temsirolimus 20 mg/m^2 Temsirolimus 25 mg
Hide Arm/Group Description:
Temsirolimus 20 milligrams per square meter (mg/m^2) intravenously (IV) once weekly until disease progression, unacceptable toxicity, or withdrawal of consent.
Temsirolimus 25 mg IV once weekly until disease progression, unacceptable toxicity, or withdrawal of consent.
Overall Number of Participants Analyzed 6 76
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
0
(0 to 0)
11.8
(5.6 to 21.3)
4.Secondary Outcome
Title Duration of Response
Hide Description Time measurement criteria are met for CR or PR (whichever status is recorded first) until the first date that recurrence or PD is objectively documented, taking as reference for PD the smallest sum longest diameters (LD) recorded since enrollment.
Time Frame Baseline Up to 4 years
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat ITT population included all participants who were enrolled in this study. Here N (number of participants analyzed) signifies participants with objective disease response.
Arm/Group Title Temsirolimus 20 mg/m^2 Temsirolimus 25 mg
Hide Arm/Group Description:
Temsirolimus 20 milligrams per square meter (mg/m^2) intravenously (IV) once weekly until disease progression, unacceptable toxicity, or withdrawal of consent.
Temsirolimus 25 mg IV once weekly until disease progression, unacceptable toxicity, or withdrawal of consent.
Overall Number of Participants Analyzed 0 9
Median (95% Confidence Interval)
Unit of Measure: months
31.3 [1] 
(4.5 to NA)
[1]
The upper limit of 95 percent (%)confidence interval (CI) is not available because there was no recurrence observation after median.
5.Secondary Outcome
Title Time to Treatment Failure (TTF)
Hide Description TTF is defined as the time from the date of enrollment to the date of the first documentation of PD, the date of treatment discontinuation except completion of treatment, or date of death due to cancer.
Time Frame Baseline Up to 4 years
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who were enrolled in this study.
Arm/Group Title Temsirolimus 20 mg/m^2 Temsirolimus 25 mg
Hide Arm/Group Description:
Temsirolimus 20 milligrams per square meter (mg/m^2) intravenously (IV) once weekly until disease progression, unacceptable toxicity, or withdrawal of consent.
Temsirolimus 25 mg IV once weekly until disease progression, unacceptable toxicity, or withdrawal of consent.
Overall Number of Participants Analyzed 6 76
Median (95% Confidence Interval)
Unit of Measure: months
7.7
(1.9 to 29.0)
5.4
(3.5 to 7.4)
6.Secondary Outcome
Title Overall Survival (OS)
Hide Description Time in months from the date of enrollment to date of death due to any cause. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death).
Time Frame Baseline Until Death (Up to 4 years)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who were enrolled in this study.
Arm/Group Title Temsirolimus 20 mg/m^2 Temsirolimus 25 mg IV
Hide Arm/Group Description:
Temsirolimus 20 milligrams per square meter (mg/m^2) intravenously (IV) once weekly until disease progression, unacceptable toxicity, or withdrawal of consent.
Temsirolimus 25 mg IV once weekly until disease progression, unacceptable toxicity, or withdrawal of consent.
Overall Number of Participants Analyzed 6 76
Median (95% Confidence Interval)
Unit of Measure: months
29.1
(4.4 to 36.3)
17.8
(13.5 to 25.3)
7.Other Pre-specified Outcome
Title Maximum Observed Plasma Concentration (Cmax)
Hide Description Sirolimus is a major metabolite of temsirolimus. As per planned analysis, only participants in "Temsirolimus 20 mg/m^2" treatment arm were to be drawn blood samples intensively for pharmacokinetic analysis.
Time Frame 0 hours (pre-dose), 0.5 hours, 1, 2, 6, 24, 72, and 96 hours during Week 1 and 4 of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic (PK) population included all participants who received at least 1 dose of study treatment and had at least 3 measurable blood concentration samples available. Here N (number of participants analyzed) signifies participants who were evaluable for this measure.
Arm/Group Title Temsirolimus 20 mg/m^2
Hide Arm/Group Description:
Temsirolimus 20 milligrams per square meter (mg/m^2) intravenously (IV) once weekly until disease progression, unacceptable toxicity, or withdrawal of consent.
Overall Number of Participants Analyzed 5
Mean (Standard Deviation)
Unit of Measure: nanogram per milliliter (ng/mL)
Cmax for temsirolimus at Week 1 704  (207)
Cmax for temsirolimus at Week 4 640  (308)
Cmax for sirolimus at Week 1 69.6  (13.1)
Cmax for sirolimus at Week 4 83.0  (38.0)
8.Other Pre-specified Outcome
Title Time to Reach Maximum Observed Plasma Concentration (Tmax)
Hide Description Sirolimus is a major metabolite of temsirolimus. As per planned analysis, only participants in "Temsirolimus 20 mg/m^2" treatment arm were to be drawn blood samples intensively for pharmacokinetic analysis.
Time Frame 0 hours (pre-dose), 0.5, 1, 2, 6, 24, 72, and 96 hours during Week 1 and 4 of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
PK population included all participants who received at least 1 dose of study treatment and had at least 3 measurable blood concentration samples available. Here N (number of participants analyzed) signifies participants who were evaluable for this measure.
Arm/Group Title Temsirolimus 20 mg/m^2
Hide Arm/Group Description:
Temsirolimus 20 milligrams per square meter (mg/m^2) intravenously (IV) once weekly until disease progression, unacceptable toxicity, or withdrawal of consent.
Overall Number of Participants Analyzed 5
Median (Full Range)
Unit of Measure: hours
Tmax for temsirolimus
0.50
(0.50 to 0.58)
Tmax for sirolimus
2.0
(2.0 to 24.0)
9.Other Pre-specified Outcome
Title Plasma Decay Half-Life (t1/2)
Hide Description Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. Sirolimus is the major metabolite of temsirolimus. As per planned analysis, only participants in "Temsirolimus 20 mg/m^2" treatment arm were to be drawn blood samples intensively for pharmacokinetic analysis.
Time Frame 0 hours (pre-dose), 0.5, 1, 2, 6, 24, 72, and 96 hours during Week 1 and 4 of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic (PK) population included all participants who received at least 1 dose of study treatment and had at least 3 measurable blood concentration samples available. Here N (number of participants analyzed) signifies participants who were evaluable for this measure.
Arm/Group Title Temsirolimus 20 mg/m^2
Hide Arm/Group Description:
Temsirolimus 20 milligrams per square meter (mg/m^2) intravenously (IV) once weekly until disease progression, unacceptable toxicity, or withdrawal of consent.
Overall Number of Participants Analyzed 5
Mean (Standard Deviation)
Unit of Measure: hours
t1/2 for temsirolimus at Week 1 18.6  (6.5)
t1/2 for temsirolimus at Week 4 18.2  (5.43)
t1/2 for sirolimus at Week 1 54.7  (15.2)
t1/2 for sirolimus at Week 4 52.4  (12.4)
10.Other Pre-specified Outcome
Title Area Under the Concentration-Time Curve (AUC)
Hide Description AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption. Sirolimus is the major metabolite of temsirolimus. As per planned analysis, only participants in "Temsirolimus 20 mg/m^2" treatment arm were to be drawn blood samples intensively for pharmacokinetic analysis.
Time Frame 0 hours (pre-dose), 0.5 hours, 1, 2, 6, 24, 72, and 96 hours during Week 1 and 4 of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
PK population included all participants who received at least 1 dose of study treatment and had at least 3 measurable blood concentration samples available. Here N (number of participants analyzed) signifies participants who were evaluable for this measure.
Arm/Group Title Temsirolimus 20 mg/m^2
Hide Arm/Group Description:
Temsirolimus 20 milligrams per square meter (mg/m^2) intravenously (IV) once weekly until disease progression, unacceptable toxicity, or withdrawal of consent.
Overall Number of Participants Analyzed 5
Mean (Standard Deviation)
Unit of Measure: ng*h/mL
AUC for temsirolimus at Week 1 2819  (1065)
AUC for temsirolimus at Week 4 2163  (822)
AUC for sirolimus at Week 1 6902  (3127)
AUC for sirolimus at Week 4 5582  (3420)
11.Other Pre-specified Outcome
Title Clearance (CLss) of Temsirolimus
Hide Description Steady state total body clearance equals infusion rate (zero order) divided by steady state plasma concentration of temsirolimus (R0/Css). As per planned analysis, only participants in "Temsirolimus 20 mg/m^2" treatment arm were to be drawn blood samples intensively for pharmacokinetic analysis.
Time Frame 0 hours (pre-dose), 0.5, 1, 2, 6, 24, 72, and 96 hours during Week 1 and 4 of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic (PK) population included all participants who received at least 1 dose of study treatment and had at least 3 measurable blood concentration samples available. Here N (number of participants analyzed) signifies participants who were evaluable for this measure.
Arm/Group Title Temsirolimus 20 mg/m^2
Hide Arm/Group Description:
Temsirolimus 20 milligrams per square meter (mg/m^2) intravenously (IV) once weekly until disease progression, unacceptable toxicity, or withdrawal of consent.
Overall Number of Participants Analyzed 5
Mean (Standard Deviation)
Unit of Measure: Liter per hour (L/h)
Week 1 13.6  (4.74)
Week 4 17.1  (5.71)
12.Other Pre-specified Outcome
Title Volume of Distribution at Steady State (Vss) of Temsirolimus
Hide Description Vss is an estimate of the volume of distribution at steady state. It is used to predict the plasma concentrations following multiple dosing to a steady-state or pseudo-equilibrium. Vss is proportional to the amount of drug in the body versus the plasma concentration of the drug at steady state. As per planned analysis, only participants in "Temsirolimus 20 mg/m^2" treatment arm were to be drawn blood samples intensively for pharmacokinetic analysis.
Time Frame 0 hours (pre-dose), 0.5, 1, 2, 6, 24, 72, and 96 hours during Week 1 and 4 of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
PK population included all participants who received at least 1 dose of study treatment and had at least 3 measurable blood concentration samples available. Here N (number of participants analyzed) signifies participants who were evaluable for this measure.
Arm/Group Title Temsirolimus 20 mg/m^2
Hide Arm/Group Description:
Temsirolimus 20 milligrams per square meter (mg/m^2) intravenously (IV) once weekly until disease progression, unacceptable toxicity, or withdrawal of consent.
Overall Number of Participants Analyzed 5
Mean (Standard Deviation)
Unit of Measure: Liter
Week 1 243  (64.7)
Week 4 250  (75.7)
Time Frame [Not Specified]
Adverse Event Reporting Description The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
 
Arm/Group Title Temsirolimus 20 mg/m^2 Temsirolimus 25 mg
Hide Arm/Group Description Temsirolimus 20 milligrams per square meter (mg/m^2) intravenously (IV) once weekly until disease progression, unacceptable toxicity, or withdrawal of consent. Temsirolimus 25 mg IV once weekly until disease progression, unacceptable toxicity, or withdrawal of consent.
All-Cause Mortality
Temsirolimus 20 mg/m^2 Temsirolimus 25 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Temsirolimus 20 mg/m^2 Temsirolimus 25 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   4/6 (66.67%)   28/76 (36.84%) 
Blood and lymphatic system disorders     
Iron deficiency anaemia * 1  0/6 (0.00%)  1/76 (1.32%) 
Cardiac disorders     
Palpitations * 1  0/6 (0.00%)  1/76 (1.32%) 
Pericardial effusion * 1  1/6 (16.67%)  0/76 (0.00%) 
Eye disorders     
Cataract subcapsular * 1  1/6 (16.67%)  0/76 (0.00%) 
Gastrointestinal disorders     
Abdominal distension * 1  0/6 (0.00%)  1/76 (1.32%) 
Abdominal hernia * 1  0/6 (0.00%)  1/76 (1.32%) 
Abdominal pain * 1  0/6 (0.00%)  2/76 (2.63%) 
Diarrhoea * 1  0/6 (0.00%)  2/76 (2.63%) 
Faecal incontinence * 1  0/6 (0.00%)  1/76 (1.32%) 
Small intestinal perforation * 1  0/6 (0.00%)  1/76 (1.32%) 
Peritoneal haemorrhage * 1  0/6 (0.00%)  1/76 (1.32%) 
Small intestinal haemorrhage * 1  0/6 (0.00%)  1/76 (1.32%) 
General disorders     
Asthenia * 1  0/6 (0.00%)  1/76 (1.32%) 
General physical health deterioration * 1  1/6 (16.67%)  0/76 (0.00%) 
Pyrexia * 1  0/6 (0.00%)  2/76 (2.63%) 
Hepatobiliary disorders     
Hepatic failure * 1  0/6 (0.00%)  1/76 (1.32%) 
Infections and infestations     
Anal abscess * 1  0/6 (0.00%)  1/76 (1.32%) 
Bronchopneumonia * 1  0/6 (0.00%)  1/76 (1.32%) 
Cellulitis * 1  1/6 (16.67%)  1/76 (1.32%) 
Lung infection * 1  0/6 (0.00%)  2/76 (2.63%) 
Pneumonia * 1  1/6 (16.67%)  6/76 (7.89%) 
Postoperative wound infection * 1  0/6 (0.00%)  1/76 (1.32%) 
Sepsis * 1  0/6 (0.00%)  1/76 (1.32%) 
Tonsillitis * 1  0/6 (0.00%)  1/76 (1.32%) 
Urinary tract infection * 1  0/6 (0.00%)  2/76 (2.63%) 
Peritonitis * 1  0/6 (0.00%)  1/76 (1.32%) 
Injury, poisoning and procedural complications     
Wound complication * 1  0/6 (0.00%)  1/76 (1.32%) 
Investigations     
Blood creatinine increased * 1  0/6 (0.00%)  1/76 (1.32%) 
Metabolism and nutrition disorders     
Hyperglycaemia * 1  0/6 (0.00%)  1/76 (1.32%) 
Musculoskeletal and connective tissue disorders     
Muscular weakness * 1  0/6 (0.00%)  1/76 (1.32%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Renal cell carcinoma * 1  0/6 (0.00%)  1/76 (1.32%) 
Tumour embolism * 1  0/6 (0.00%)  1/76 (1.32%) 
Tumour pain * 1  0/6 (0.00%)  1/76 (1.32%) 
Nervous system disorders     
Cerebral haemorrhage * 1  0/6 (0.00%)  1/76 (1.32%) 
Spinal cord compression * 1  0/6 (0.00%)  1/76 (1.32%) 
Paraplegia * 1  0/6 (0.00%)  1/76 (1.32%) 
Psychiatric disorders     
Delirium * 1  0/6 (0.00%)  1/76 (1.32%) 
Completed suicide * 1  0/6 (0.00%)  1/76 (1.32%) 
Renal and urinary disorders     
Renal failure * 1  0/6 (0.00%)  1/76 (1.32%) 
Renal failure acute * 1  0/6 (0.00%)  1/76 (1.32%) 
Azotaemia * 1  0/6 (0.00%)  1/76 (1.32%) 
Haematuria * 1  0/6 (0.00%)  1/76 (1.32%) 
Renal impairment * 1  0/6 (0.00%)  1/76 (1.32%) 
Respiratory, thoracic and mediastinal disorders     
Atelectasis * 1  0/6 (0.00%)  1/76 (1.32%) 
Cough * 1  0/6 (0.00%)  1/76 (1.32%) 
Dyspnoea * 1  0/6 (0.00%)  2/76 (2.63%) 
Haemoptysis * 1  0/6 (0.00%)  1/76 (1.32%) 
Interstitial lung disease * 1  2/6 (33.33%)  4/76 (5.26%) 
Pleural effusion * 1  0/6 (0.00%)  2/76 (2.63%) 
Respiratory failure * 1  0/6 (0.00%)  2/76 (2.63%) 
Vascular disorders     
Circulatory collapse * 1  0/6 (0.00%)  1/76 (1.32%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Temsirolimus 20 mg/m^2 Temsirolimus 25 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   6/6 (100.00%)   76/76 (100.00%) 
Blood and lymphatic system disorders     
Anaemia * 1  5/6 (83.33%)  23/76 (30.26%) 
Eosinophilia * 1  0/6 (0.00%)  1/76 (1.32%) 
Granulocytopenia * 1  0/6 (0.00%)  1/76 (1.32%) 
Iron deficiency anaemia * 1  0/6 (0.00%)  1/76 (1.32%) 
Leukopenia * 1  2/6 (33.33%)  7/76 (9.21%) 
Lymphopenia * 1  2/6 (33.33%)  8/76 (10.53%) 
Neutropenia * 1  2/6 (33.33%)  3/76 (3.95%) 
Thrombocytopenia * 1  1/6 (16.67%)  9/76 (11.84%) 
Cardiac disorders     
Palpitations * 1  0/6 (0.00%)  3/76 (3.95%) 
Tachycardia * 1  2/6 (33.33%)  1/76 (1.32%) 
Cardiac valve disease * 1  1/6 (16.67%)  0/76 (0.00%) 
Pericardial effusion * 1  1/6 (16.67%)  0/76 (0.00%) 
Ear and labyrinth disorders     
Ear pain * 1  0/6 (0.00%)  1/76 (1.32%) 
Otorrhoea * 1  1/6 (16.67%)  0/76 (0.00%) 
Endocrine disorders     
Cushing's syndrome * 1  0/6 (0.00%)  1/76 (1.32%) 
Eye disorders     
Blepharitis * 1  0/6 (0.00%)  1/76 (1.32%) 
Cataract * 1  0/6 (0.00%)  1/76 (1.32%) 
Conjunctival hyperaemia * 1  1/6 (16.67%)  0/76 (0.00%) 
Diabetic retinopathy * 1  0/6 (0.00%)  1/76 (1.32%) 
Dry eye * 1  0/6 (0.00%)  2/76 (2.63%) 
Eyelid oedema * 1  0/6 (0.00%)  1/76 (1.32%) 
Lacrimation increased * 1  0/6 (0.00%)  1/76 (1.32%) 
Vision blurred * 1  0/6 (0.00%)  2/76 (2.63%) 
Visual impairment * 1  0/6 (0.00%)  1/76 (1.32%) 
Cataract subcapsular * 1  1/6 (16.67%)  0/76 (0.00%) 
Periorbital oedema * 1  0/6 (0.00%)  3/76 (3.95%) 
Gastrointestinal disorders     
Abdominal discomfort * 1  1/6 (16.67%)  9/76 (11.84%) 
Abdominal distension * 1  0/6 (0.00%)  6/76 (7.89%) 
Abdominal hernia * 1  0/6 (0.00%)  1/76 (1.32%) 
Abdominal pain * 1  0/6 (0.00%)  8/76 (10.53%) 
Abdominal pain lower * 1  0/6 (0.00%)  2/76 (2.63%) 
Abdominal pain upper * 1  0/6 (0.00%)  2/76 (2.63%) 
Anal fissure * 1  0/6 (0.00%)  1/76 (1.32%) 
Anorectal discomfort * 1  0/6 (0.00%)  4/76 (5.26%) 
Aphthous stomatitis * 1  0/6 (0.00%)  2/76 (2.63%) 
Ascites * 1  0/6 (0.00%)  1/76 (1.32%) 
Cheilitis * 1  2/6 (33.33%)  4/76 (5.26%) 
Constipation * 1  3/6 (50.00%)  17/76 (22.37%) 
Dental caries * 1  1/6 (16.67%)  2/76 (2.63%) 
Diarrhoea * 1  4/6 (66.67%)  17/76 (22.37%) 
Dyspepsia * 1  0/6 (0.00%)  2/76 (2.63%) 
Dysphagia * 1  0/6 (0.00%)  2/76 (2.63%) 
Epigastric discomfort * 1  0/6 (0.00%)  1/76 (1.32%) 
Faeces discoloured * 1  1/6 (16.67%)  0/76 (0.00%) 
Gastritis * 1  1/6 (16.67%)  1/76 (1.32%) 
Gingival pain * 1  0/6 (0.00%)  2/76 (2.63%) 
Gingivitis * 1  0/6 (0.00%)  3/76 (3.95%) 
Glossitis * 1  0/6 (0.00%)  1/76 (1.32%) 
Haemorrhoids * 1  0/6 (0.00%)  1/76 (1.32%) 
Mouth ulceration * 1  0/6 (0.00%)  9/76 (11.84%) 
Nausea * 1  0/6 (0.00%)  18/76 (23.68%) 
Periodontitis * 1  1/6 (16.67%)  5/76 (6.58%) 
Proctalgia * 1  0/6 (0.00%)  1/76 (1.32%) 
Radicular cyst * 1  0/6 (0.00%)  1/76 (1.32%) 
Small intestinal haemorrhage * 1  0/6 (0.00%)  1/76 (1.32%) 
Stomatitis * 1  5/6 (83.33%)  42/76 (55.26%) 
Toothache * 1  2/6 (33.33%)  1/76 (1.32%) 
Vomiting * 1  3/6 (50.00%)  11/76 (14.47%) 
Breath odour * 1  1/6 (16.67%)  0/76 (0.00%) 
Gingival ulceration * 1  0/6 (0.00%)  1/76 (1.32%) 
General disorders     
Asthenia * 1  0/6 (0.00%)  10/76 (13.16%) 
Axillary pain * 1  1/6 (16.67%)  0/76 (0.00%) 
Chest discomfort * 1  0/6 (0.00%)  6/76 (7.89%) 
Chest pain * 1  0/6 (0.00%)  2/76 (2.63%) 
Chills * 1  1/6 (16.67%)  6/76 (7.89%) 
Face oedema * 1  1/6 (16.67%)  9/76 (11.84%) 
Fatigue * 1  3/6 (50.00%)  25/76 (32.89%) 
Gait disturbance * 1  0/6 (0.00%)  1/76 (1.32%) 
General physical health deterioration * 1  2/6 (33.33%)  2/76 (2.63%) 
Generalised oedema * 1  0/6 (0.00%)  1/76 (1.32%) 
Hypothermia * 1  0/6 (0.00%)  1/76 (1.32%) 
Injection site reaction * 1  0/6 (0.00%)  1/76 (1.32%) 
Influenza like illness * 1  0/6 (0.00%)  5/76 (6.58%) 
Localised oedema * 1  0/6 (0.00%)  1/76 (1.32%) 
Malaise * 1  1/6 (16.67%)  1/76 (1.32%) 
Mucosal inflammation * 1  0/6 (0.00%)  4/76 (5.26%) 
Non-cardiac chest pain * 1  0/6 (0.00%)  3/76 (3.95%) 
Oedema * 1  1/6 (16.67%)  3/76 (3.95%) 
Oedema peripheral * 1  1/6 (16.67%)  13/76 (17.11%) 
Pyrexia * 1  3/6 (50.00%)  28/76 (36.84%) 
Thirst * 1  0/6 (0.00%)  1/76 (1.32%) 
Hepatobiliary disorders     
Cholecystitis * 1  0/6 (0.00%)  1/76 (1.32%) 
Hepatic function abnormal * 1  0/6 (0.00%)  1/76 (1.32%) 
Immune system disorders     
Drug hypersensitivity * 1  0/6 (0.00%)  2/76 (2.63%) 
Infections and infestations     
Adenoviral conjunctivitis * 1  1/6 (16.67%)  0/76 (0.00%) 
Bronchitis * 1  1/6 (16.67%)  2/76 (2.63%) 
Cellulitis * 1  1/6 (16.67%)  1/76 (1.32%) 
Cystitis * 1  0/6 (0.00%)  1/76 (1.32%) 
Folliculitis * 1  0/6 (0.00%)  3/76 (3.95%) 
Herpes virus infection * 1  0/6 (0.00%)  1/76 (1.32%) 
Herpes zoster * 1  0/6 (0.00%)  1/76 (1.32%) 
Hordeolum * 1  0/6 (0.00%)  2/76 (2.63%) 
Oral herpes * 1  0/6 (0.00%)  1/76 (1.32%) 
Localised infection * 1  0/6 (0.00%)  1/76 (1.32%) 
Lung infection * 1  0/6 (0.00%)  2/76 (2.63%) 
Nail infection * 1  1/6 (16.67%)  1/76 (1.32%) 
Nasopharyngitis * 1  1/6 (16.67%)  8/76 (10.53%) 
Onychomycosis * 1  0/6 (0.00%)  1/76 (1.32%) 
Otitis media * 1  1/6 (16.67%)  1/76 (1.32%) 
Paronychia * 1  0/6 (0.00%)  7/76 (9.21%) 
Pharyngitis * 1  0/6 (0.00%)  1/76 (1.32%) 
Pneumonia * 1  1/6 (16.67%)  5/76 (6.58%) 
Rash pustular * 1  0/6 (0.00%)  1/76 (1.32%) 
Sinusitis * 1  1/6 (16.67%)  2/76 (2.63%) 
Sputum purulent * 1  1/6 (16.67%)  0/76 (0.00%) 
Tooth infection * 1  0/6 (0.00%)  1/76 (1.32%) 
Upper respiratory tract infection * 1  0/6 (0.00%)  20/76 (26.32%) 
Urinary tract infection * 1  0/6 (0.00%)  2/76 (2.63%) 
Injury, poisoning and procedural complications     
Excoriation * 1  2/6 (33.33%)  1/76 (1.32%) 
Foot fracture * 1  0/6 (0.00%)  1/76 (1.32%) 
Head injury * 1  1/6 (16.67%)  0/76 (0.00%) 
Mouth injury * 1  1/6 (16.67%)  0/76 (0.00%) 
Ligament sprain * 1  0/6 (0.00%)  1/76 (1.32%) 
Post procedural complication * 1  1/6 (16.67%)  0/76 (0.00%) 
Post procedural discharge * 1  0/6 (0.00%)  1/76 (1.32%) 
Wound complication * 1  1/6 (16.67%)  1/76 (1.32%) 
Laceration * 1  0/6 (0.00%)  1/76 (1.32%) 
Investigations     
Activated partial thromboplastin time prolonged * 1  1/6 (16.67%)  2/76 (2.63%) 
Alanine aminotransferase increased * 1  5/6 (83.33%)  23/76 (30.26%) 
Aspartate aminotransferase increased * 1  5/6 (83.33%)  23/76 (30.26%) 
Bacterial test positive * 1  0/6 (0.00%)  1/76 (1.32%) 
Blood albumin decreased * 1  3/6 (50.00%)  3/76 (3.95%) 
Blood alkaline phosphatase * 1  0/6 (0.00%)  2/76 (2.63%) 
Blood alkaline phosphatase increased * 1  4/6 (66.67%)  12/76 (15.79%) 
Blood calcium decreased * 1  2/6 (33.33%)  3/76 (3.95%) 
Blood magnesium increased * 1  1/6 (16.67%)  0/76 (0.00%) 
Blood chloride increased * 1  0/6 (0.00%)  2/76 (2.63%) 
Blood cholesterol increased * 1  2/6 (33.33%)  12/76 (15.79%) 
Blood creatine increased * 1  0/6 (0.00%)  3/76 (3.95%) 
Blood creatine phosphokinase increased * 1  0/6 (0.00%)  2/76 (2.63%) 
Blood creatinine * 1  0/6 (0.00%)  4/76 (5.26%) 
Blood creatinine increased * 1  2/6 (33.33%)  20/76 (26.32%) 
Blood glucose increased * 1  0/6 (0.00%)  9/76 (11.84%) 
Blood iron decreased * 1  1/6 (16.67%)  0/76 (0.00%) 
Blood lactate dehydrogenase * 1  0/6 (0.00%)  2/76 (2.63%) 
Blood lactate dehydrogenase decreased * 1  0/6 (0.00%)  2/76 (2.63%) 
Blood lactate dehydrogenase increased * 1  3/6 (50.00%)  13/76 (17.11%) 
Blood phosphorus decreased * 1  1/6 (16.67%)  2/76 (2.63%) 
Blood potassium decreased * 1  1/6 (16.67%)  2/76 (2.63%) 
Blood potassium increased * 1  1/6 (16.67%)  2/76 (2.63%) 
Blood pressure increased * 1  0/6 (0.00%)  1/76 (1.32%) 
Blood sodium decreased * 1  1/6 (16.67%)  2/76 (2.63%) 
Blood triglycerides increased * 1  3/6 (50.00%)  16/76 (21.05%) 
Blood urea * 1  0/6 (0.00%)  1/76 (1.32%) 
Blood urea increased * 1  0/6 (0.00%)  4/76 (5.26%) 
C-reactive protein increased * 1  2/6 (33.33%)  2/76 (2.63%) 
Carbon monoxide diffusing capacity decreased * 1  0/6 (0.00%)  1/76 (1.32%) 
Gamma-glutamyltransferase increased * 1  3/6 (50.00%)  7/76 (9.21%) 
Glycosylated haemoglobin increased * 1  2/6 (33.33%)  7/76 (9.21%) 
Haematocrit decreased * 1  0/6 (0.00%)  5/76 (6.58%) 
Haemoglobin * 1  0/6 (0.00%)  1/76 (1.32%) 
Haemoglobin decreased * 1  1/6 (16.67%)  23/76 (30.26%) 
Lymphocyte count decreased * 1  0/6 (0.00%)  1/76 (1.32%) 
Neutrophil count decreased * 1  0/6 (0.00%)  6/76 (7.89%) 
Neutrophil count increased * 1  1/6 (16.67%)  1/76 (1.32%) 
Platelet count decreased * 1  3/6 (50.00%)  18/76 (23.68%) 
Platelet count increased * 1  1/6 (16.67%)  3/76 (3.95%) 
Protein total decreased * 1  1/6 (16.67%)  1/76 (1.32%) 
Protein total increased * 1  1/6 (16.67%)  4/76 (5.26%) 
Prothrombin time prolonged * 1  4/6 (66.67%)  0/76 (0.00%) 
Pulmonary function test abnormal * 1  0/6 (0.00%)  1/76 (1.32%) 
Pulmonary function test decreased * 1  0/6 (0.00%)  1/76 (1.32%) 
Red blood cell count decreased * 1  0/6 (0.00%)  4/76 (5.26%) 
Red blood cell count increased * 1  0/6 (0.00%)  2/76 (2.63%) 
Urine output decreased * 1  0/6 (0.00%)  1/76 (1.32%) 
Weight decreased * 1  5/6 (83.33%)  18/76 (23.68%) 
Weight increased * 1  0/6 (0.00%)  4/76 (5.26%) 
White blood cell count decreased * 1  0/6 (0.00%)  14/76 (18.42%) 
White blood cell count increased * 1  1/6 (16.67%)  3/76 (3.95%) 
Chest X-ray abnormal * 1  0/6 (0.00%)  1/76 (1.32%) 
Metabolism and nutrition disorders     
Decreased appetite * 1  1/6 (16.67%)  35/76 (46.05%) 
Diabetes mellitus * 1  3/6 (50.00%)  2/76 (2.63%) 
Dyslipidaemia * 1  0/6 (0.00%)  1/76 (1.32%) 
Hypercalcaemia * 1  0/6 (0.00%)  6/76 (7.89%) 
Hypercholesterolaemia * 1  2/6 (33.33%)  34/76 (44.74%) 
Hyperglycaemia * 1  3/6 (50.00%)  28/76 (36.84%) 
Hyperkalaemia * 1  1/6 (16.67%)  4/76 (5.26%) 
Hyperlipidaemia * 1  0/6 (0.00%)  4/76 (5.26%) 
Hypermagnesaemia * 1  0/6 (0.00%)  7/76 (9.21%) 
Hypernatraemia * 1  0/6 (0.00%)  2/76 (2.63%) 
Hyperphosphataemia * 1  0/6 (0.00%)  1/76 (1.32%) 
Hyperphosphatasaemia * 1  0/6 (0.00%)  1/76 (1.32%) 
Hypertriglyceridaemia * 1  2/6 (33.33%)  31/76 (40.79%) 
Hyperuricaemia * 1  0/6 (0.00%)  1/76 (1.32%) 
Hypoalbuminaemia * 1  0/6 (0.00%)  6/76 (7.89%) 
Hypocalcaemia * 1  1/6 (16.67%)  12/76 (15.79%) 
Hypoglycaemia * 1  0/6 (0.00%)  3/76 (3.95%) 
Hypokalaemia * 1  1/6 (16.67%)  8/76 (10.53%) 
Hyponatraemia * 1  1/6 (16.67%)  8/76 (10.53%) 
Hypophagia * 1  0/6 (0.00%)  1/76 (1.32%) 
Hypophosphataemia * 1  3/6 (50.00%)  28/76 (36.84%) 
Metabolic acidosis * 1  0/6 (0.00%)  1/76 (1.32%) 
Hyperchloraemia * 1  0/6 (0.00%)  3/76 (3.95%) 
Hypochloraemia * 1  0/6 (0.00%)  1/76 (1.32%) 
Musculoskeletal and connective tissue disorders     
Arthralgia * 1  0/6 (0.00%)  9/76 (11.84%) 
Arthritis * 1  0/6 (0.00%)  2/76 (2.63%) 
Back pain * 1  3/6 (50.00%)  8/76 (10.53%) 
Flank pain * 1  0/6 (0.00%)  5/76 (6.58%) 
Groin pain * 1  0/6 (0.00%)  1/76 (1.32%) 
Joint swelling * 1  0/6 (0.00%)  1/76 (1.32%) 
Muscle spasms * 1  0/6 (0.00%)  1/76 (1.32%) 
Muscular weakness * 1  0/6 (0.00%)  1/76 (1.32%) 
Musculoskeletal chest pain * 1  0/6 (0.00%)  3/76 (3.95%) 
Musculoskeletal discomfort * 1  1/6 (16.67%)  2/76 (2.63%) 
Musculoskeletal pain * 1  1/6 (16.67%)  3/76 (3.95%) 
Musculoskeletal stiffness * 1  1/6 (16.67%)  0/76 (0.00%) 
Myalgia * 1  0/6 (0.00%)  11/76 (14.47%) 
Pain in extremity * 1  0/6 (0.00%)  2/76 (2.63%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Cancer pain * 1  0/6 (0.00%)  1/76 (1.32%) 
Metastatic pain * 1  0/6 (0.00%)  1/76 (1.32%) 
Tumour pain * 1  0/6 (0.00%)  2/76 (2.63%) 
Nervous system disorders     
Dizziness * 1  0/6 (0.00%)  5/76 (6.58%) 
Dysgeusia * 1  3/6 (50.00%)  7/76 (9.21%) 
Headache * 1  1/6 (16.67%)  6/76 (7.89%) 
Neuropathy peripheral * 1  3/6 (50.00%)  0/76 (0.00%) 
Parosmia * 1  1/6 (16.67%)  0/76 (0.00%) 
Post herpetic neuralgia * 1  0/6 (0.00%)  1/76 (1.32%) 
Somnolence * 1  0/6 (0.00%)  3/76 (3.95%) 
Tremor * 1  0/6 (0.00%)  1/76 (1.32%) 
Spinal cord compression * 1  0/6 (0.00%)  1/76 (1.32%) 
Psychiatric disorders     
Anxiety * 1  0/6 (0.00%)  1/76 (1.32%) 
Breath holding * 1  0/6 (0.00%)  1/76 (1.32%) 
Depressed mood * 1  0/6 (0.00%)  2/76 (2.63%) 
Insomnia * 1  0/6 (0.00%)  8/76 (10.53%) 
Renal and urinary disorders     
Azotaemia * 1  0/6 (0.00%)  2/76 (2.63%) 
Hydronephrosis * 1  0/6 (0.00%)  1/76 (1.32%) 
Incontinence * 1  0/6 (0.00%)  1/76 (1.32%) 
Micturition urgency * 1  0/6 (0.00%)  1/76 (1.32%) 
Nocturia * 1  0/6 (0.00%)  1/76 (1.32%) 
Pollakiuria * 1  1/6 (16.67%)  3/76 (3.95%) 
Polyuria * 1  0/6 (0.00%)  1/76 (1.32%) 
Proteinuria * 1  1/6 (16.67%)  1/76 (1.32%) 
Renal failure acute * 1  0/6 (0.00%)  1/76 (1.32%) 
Urinary retention * 1  0/6 (0.00%)  1/76 (1.32%) 
Urinary tract obstruction * 1  0/6 (0.00%)  1/76 (1.32%) 
Urinary tract pain * 1  0/6 (0.00%)  1/76 (1.32%) 
Urine abnormality * 1  0/6 (0.00%)  1/76 (1.32%) 
Reproductive system and breast disorders     
Menstruation delayed * 1  0/6 (0.00%)  1/76 (1.32%) 
Menstruation irregular * 1  0/6 (0.00%)  1/76 (1.32%) 
Pelvic pain * 1  0/6 (0.00%)  4/76 (5.26%) 
Testicular swelling * 1  0/6 (0.00%)  1/76 (1.32%) 
Respiratory, thoracic and mediastinal disorders     
Atelectasis * 1  0/6 (0.00%)  1/76 (1.32%) 
Cough * 1  2/6 (33.33%)  19/76 (25.00%) 
Dyspnoea * 1  0/6 (0.00%)  16/76 (21.05%) 
Dyspnoea exertional * 1  1/6 (16.67%)  5/76 (6.58%) 
Epistaxis * 1  3/6 (50.00%)  15/76 (19.74%) 
Haemoptysis * 1  0/6 (0.00%)  9/76 (11.84%) 
Hiccups * 1  0/6 (0.00%)  1/76 (1.32%) 
Hypoxia * 1  1/6 (16.67%)  2/76 (2.63%) 
Interstitial lung disease * 1  2/6 (33.33%)  12/76 (15.79%) 
Nasal disorder * 1  0/6 (0.00%)  3/76 (3.95%) 
Nasal dryness * 1  1/6 (16.67%)  0/76 (0.00%) 
Oropharyngeal pain * 1  1/6 (16.67%)  10/76 (13.16%) 
Pleural effusion * 1  1/6 (16.67%)  4/76 (5.26%) 
Pleuritic pain * 1  0/6 (0.00%)  2/76 (2.63%) 
Productive cough * 1  0/6 (0.00%)  7/76 (9.21%) 
Pulmonary hypertension * 1  3/6 (50.00%)  0/76 (0.00%) 
Rhinorrhoea * 1  3/6 (50.00%)  1/76 (1.32%) 
Upper respiratory tract inflammation * 1  1/6 (16.67%)  1/76 (1.32%) 
Hydrothorax * 1  0/6 (0.00%)  1/76 (1.32%) 
Lower respiratory tract inflammation * 1  1/6 (16.67%)  0/76 (0.00%) 
Oropharyngeal discomfort * 1  0/6 (0.00%)  1/76 (1.32%) 
Respiratory gas exchange disorder * 1  0/6 (0.00%)  1/76 (1.32%) 
Skin and subcutaneous tissue disorders     
Acne * 1  2/6 (33.33%)  3/76 (3.95%) 
Alopecia * 1  1/6 (16.67%)  0/76 (0.00%) 
Blister * 1  0/6 (0.00%)  1/76 (1.32%) 
Blood blister * 1  0/6 (0.00%)  1/76 (1.32%) 
Dermatitis * 1  1/6 (16.67%)  1/76 (1.32%) 
Dermatitis acneiform * 1  0/6 (0.00%)  4/76 (5.26%) 
Dry skin * 1  1/6 (16.67%)  2/76 (2.63%) 
Erythema multiforme * 1  0/6 (0.00%)  1/76 (1.32%) 
Exfoliative rash * 1  0/6 (0.00%)  4/76 (5.26%) 
Hyperhidrosis * 1  0/6 (0.00%)  2/76 (2.63%) 
Nail disorder * 1  4/6 (66.67%)  20/76 (26.32%) 
Palmar erythema * 1  0/6 (0.00%)  1/76 (1.32%) 
Palmar-plantar erythrodysaesthesia syndrome * 1  2/6 (33.33%)  7/76 (9.21%) 
Pigmentation disorder * 1  0/6 (0.00%)  2/76 (2.63%) 
Pruritus * 1  1/6 (16.67%)  23/76 (30.26%) 
Rash * 1  6/6 (100.00%)  43/76 (56.58%) 
Rash maculo-papular * 1  0/6 (0.00%)  1/76 (1.32%) 
Rash pruritic * 1  0/6 (0.00%)  1/76 (1.32%) 
Scar * 1  0/6 (0.00%)  1/76 (1.32%) 
Seborrhoeic dermatitis * 1  1/6 (16.67%)  0/76 (0.00%) 
Skin disorder * 1  0/6 (0.00%)  1/76 (1.32%) 
Skin erosion * 1  0/6 (0.00%)  2/76 (2.63%) 
Skin exfoliation * 1  0/6 (0.00%)  6/76 (7.89%) 
Skin hyperpigmentation * 1  2/6 (33.33%)  1/76 (1.32%) 
Skin reaction * 1  1/6 (16.67%)  1/76 (1.32%) 
Subcutaneous nodule * 1  0/6 (0.00%)  1/76 (1.32%) 
Urticaria * 1  0/6 (0.00%)  1/76 (1.32%) 
Yellow skin * 1  0/6 (0.00%)  1/76 (1.32%) 
Pruritus generalised * 1  0/6 (0.00%)  2/76 (2.63%) 
Vascular disorders     
Flushing * 1  0/6 (0.00%)  1/76 (1.32%) 
Hot flush * 1  2/6 (33.33%)  0/76 (0.00%) 
Hypertension * 1  0/6 (0.00%)  11/76 (14.47%) 
Phlebitis * 1  1/6 (16.67%)  2/76 (2.63%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA
[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.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
EMail: ClinicalTrials.gov_Inquiries@pfizer.com
Layout table for additonal information
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00494091    
Other Study ID Numbers: 3066K1-2217
B1771002
First Submitted: June 28, 2007
First Posted: June 29, 2007
Results First Submitted: May 31, 2012
Results First Posted: July 9, 2012
Last Update Posted: March 21, 2013