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Trial record 1 of 1 for:    A4061035
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Study Of AG-013736 (Axitinib) As Second-Line Treatment In Patients With Metastatic Renal Cell Cancer (mRCC)

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ClinicalTrials.gov Identifier: NCT00569946
Recruitment Status : Completed
First Posted : December 10, 2007
Results First Posted : March 27, 2012
Last Update Posted : June 5, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Masking: None (Open Label);   Primary Purpose: Treatment
Condition Carcinoma, Renal Cell
Intervention Drug: AG-013736
Enrollment 64
Recruitment Details  
Pre-assignment Details  
Arm/Group Title AG-013736
Hide Arm/Group Description The starting dose of AG-013736 was 5 mg twice daily (BID), which was administered orally at approximately 12 hours apart in cycles of 4 weeks (28 days). The treatment is to be continued until the participants meet the discontinuation criteria such as disease progression or intolerable toxicity. The dose of AG-013736 could be titrated to 7 mg BID, and then 10 mg BID or reduced to 3 mg BID, and then 2 mg BID depending on the grade, type, and causality of adverse events experienced.
Period Title: Overall Study
Started 64
Completed 5
Not Completed 59
Reason Not Completed
Adverse Event             16
Objective Progression or Relapse             42
Global Deterioration of Health Status             1
Arm/Group Title AG-013736
Hide Arm/Group Description The starting dose of AG-013736 was 5 mg twice daily (BID), which was administered orally at approximately 12 hours apart in cycles of 4 weeks (28 days). The treatment is to be continued until the participants meet the discontinuation criteria such as disease progression or intolerable toxicity. The dose of AG-013736 could be titrated to 7 mg BID, and then 10 mg BID or reduced to 3 mg BID, and then 2 mg BID depending on the grade, type, and causality of adverse events experienced.
Overall Number of Baseline Participants 64
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 64 participants
<18
0
   0.0%
18-44
6
   9.4%
45-64
30
  46.9%
>= 65
28
  43.8%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 64 participants
Female
20
  31.3%
Male
44
  68.8%
1.Primary Outcome
Title Objective Response Rate (Percentage of Participants With Complete Response [CR] or Partial Response [PR]): Independent Review Committee Assessment
Hide Description Percentage of participants with objective response based assessment of confirmed CR or confirmed PR by the Independent Review Committee, according to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.0). CR was defined as the disappearance of all target and nontarget lesions and no appearance of new lesions. PR was defined as at least a 30% decrease in the sum of the longest diameters of the targeted lesions. CR and PR had to be documented on 2 occasions separated by at least 4 weeks.
Time Frame Up to 765 days of treatment at the data cut-off date
Hide Outcome Measure Data
Hide Analysis Population Description
The Intent-To-Treat (ITT) population included all participants enrolled in the study who received at least 1 dose of study medication.
Arm/Group Title AG-013736
Hide Arm/Group Description:
The starting dose of AG-013736 was 5 mg twice daily (BID), which was administered orally at approximately 12 hours apart in cycles of 4 weeks (28 days). The treatment is to be continued until the participants meet the discontinuation criteria such as disease progression or intolerable toxicity. The dose of AG-013736 could be titrated to 7 mg BID, and then 10 mg BID or reduced to 3 mg BID, and then 2 mg BID depending on the grade, type, and causality of adverse events experienced.
Overall Number of Participants Analyzed 64
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
50.0
(37.2 to 62.8)
2.Primary Outcome
Title Objective Response Rate (Percentage of Participants With Complete Response [CR] or Partial Response [PR]): Investigators Assessment
Hide Description Percentage of participants with objective response based assessment of confirmed CR or confirmed PR by the investigator, according to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.0). CR was defined as the disappearance of all target and nontarget lesions and no appearance of new lesions. PR was defined as at least a 30% decrease in the sum of the longest diameters of the targeted lesions. CR and PR had to be documented on 2 occasions separated by at least 4 weeks.
Time Frame Up to 765 days of treatment at the data cut-off date
Hide Outcome Measure Data
Hide Analysis Population Description
The Intent-To-Treat (ITT) population included all participants enrolled in the study who received at least 1 dose of study medication.
Arm/Group Title AG-013736
Hide Arm/Group Description:
The starting dose of AG-013736 was 5 mg twice daily (BID), which was administered orally at approximately 12 hours apart in cycles of 4 weeks (28 days). The treatment is to be continued until the participants meet the discontinuation criteria such as disease progression or intolerable toxicity. The dose of AG-013736 could be titrated to 7 mg BID, and then 10 mg BID or reduced to 3 mg BID, and then 2 mg BID depending on the grade, type, and causality of adverse events experienced.
Overall Number of Participants Analyzed 64
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
54.7
(41.7 to 67.2)
3.Secondary Outcome
Title Progression-Free Survival (PFS)
Hide Description Time in months from start of study treatment to first documentation of objective tumor progression or death due to any cause whichever comes first. PFS was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 30.44. Tumor progression was determined from radiological image (where data meet the criteria for progressive disease [PD]).
Time Frame Up to 1709 days of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
The Intent-To-Treat (ITT) population included all participants enrolled in the study who received at least 1 dose of study medication.
Arm/Group Title AG-013736
Hide Arm/Group Description:
The starting dose of AG-013736 was 5 mg twice daily (BID), which was administered orally at approximately 12 hours apart in cycles of 4 weeks (28 days). The treatment is to be continued until the participants meet the discontinuation criteria such as disease progression or intolerable toxicity. The dose of AG-013736 could be titrated to 7 mg BID, and then 10 mg BID or reduced to 3 mg BID, and then 2 mg BID depending on the grade, type, and causality of adverse events experienced.
Overall Number of Participants Analyzed 64
Median (95% Confidence Interval)
Unit of Measure: months
Independent Review Committee Assessment
11.0
(9.2 to 12.0)
Investigators Assessment
12.0
(9.2 to 14.8)
4.Secondary Outcome
Title Time to Tumor Progression (TTP)
Hide Description Time in months from start of study treatment to first documentation of objective tumor progression. TTP was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 30.44. Tumor progression was determined from radiological image (where data meet the criteria for progressive disease [PD]).
Time Frame Up to 1709 days of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
The Intent-To-Treat (ITT) population included all participants enrolled in the study who received at least 1 dose of study medication.
Arm/Group Title AG-013736
Hide Arm/Group Description:
The starting dose of AG-013736 was 5 mg twice daily (BID), which was administered orally at approximately 12 hours apart in cycles of 4 weeks (28 days). The treatment is to be continued until the participants meet the discontinuation criteria such as disease progression or intolerable toxicity. The dose of AG-013736 could be titrated to 7 mg BID, and then 10 mg BID or reduced to 3 mg BID, and then 2 mg BID depending on the grade, type, and causality of adverse events experienced.
Overall Number of Participants Analyzed 64
Median (95% Confidence Interval)
Unit of Measure: months
Independent Review Committee Assessment
11.0
(9.2 to 12.0)
Investigators Assessment
12.0
(9.2 to 14.8)
5.Secondary Outcome
Title Duration of Response
Hide Description Time in months from the first documentation of objective tumor response to objective tumor progression or death due to any cause. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 30.44. DR was calculated for the subgroup of participants with a confirmed objective tumor response.
Time Frame Start of first confirmed CR or PR to the date of the first event (PD or death) or the last tumor assessment, whichever came first, assessed up to 1709 days.
Hide Outcome Measure Data
Hide Analysis Population Description
The Intent-To-Treat (ITT) population included all participants enrolled in the study who received at least 1 dose of study medication. DR was calculated for the subgroup of participants with a confirmed objective tumor response. n=number of participants assessed as CR or PR.
Arm/Group Title AG-013736
Hide Arm/Group Description:
The starting dose of AG-013736 was 5 mg twice daily (BID), which was administered orally at approximately 12 hours apart in cycles of 4 weeks (28 days). The treatment is to be continued until the participants meet the discontinuation criteria such as disease progression or intolerable toxicity. The dose of AG-013736 could be titrated to 7 mg BID, and then 10 mg BID or reduced to 3 mg BID, and then 2 mg BID depending on the grade, type, and causality of adverse events experienced.
Overall Number of Participants Analyzed 64
Median (95% Confidence Interval)
Unit of Measure: months
Independent Review Committee Assessment (n=33)
11.1
(8.2 to 13.7)
Investigators Assessment (n=36)
12.8
(7.7 to 17.5)
6.Secondary Outcome
Title Overall Survival (OS)
Hide Description

OS was defined as the time from date of first dose of AG-013736 to date of death due to any cause.

Subjects in whom death is not reported will have their event time censored on the last date the subject is known to be alive.

Time Frame Up to 2002 days (maximum duration of treatment plus follow-up observation)
Hide Outcome Measure Data
Hide Analysis Population Description
The Intent-To-Treat (ITT) population included all participants enrolled in the study who received at least 1 dose of study medication.
Arm/Group Title AG-013736
Hide Arm/Group Description:
The starting dose of AG-013736 was 5 mg twice daily (BID), which was administered orally at approximately 12 hours apart in cycles of 4 weeks (28 days). The treatment is to be continued until the participants meet the discontinuation criteria such as disease progression or intolerable toxicity. The dose of AG-013736 could be titrated to 7 mg BID, and then 10 mg BID or reduced to 3 mg BID, and then 2 mg BID depending on the grade, type, and causality of adverse events experienced.
Overall Number of Participants Analyzed 64
Median (95% Confidence Interval)
Unit of Measure: months
37.3
(28.6 to 49.9)
7.Secondary Outcome
Title Number of Participants Analyzed for Population Pharmacokinetics of AG-013736
Hide Description Population pharmacokinetic analysis of AG-013736 is conducted by combining current study data with other AG-013736 studies.
Time Frame Cycle 1 Day 1 (2 hours after morning dose); Cycles 3, 5, and 7 Day 1 predose and 2 hours post morning dose
Hide Outcome Measure Data
Hide Analysis Population Description
No population pharmacokinetic analysis results are available just for the current study.
Arm/Group Title AG-013736
Hide Arm/Group Description:
The starting dose of AG-013736 was 5 mg twice daily (BID), which was administered orally at approximately 12 hours apart in cycles of 4 weeks (28 days). The treatment is to be continued until the participants meet the discontinuation criteria such as disease progression or intolerable toxicity. The dose of AG-013736 could be titrated to 7 mg BID, and then 10 mg BID or reduced to 3 mg BID, and then 2 mg BID depending on the grade, type, and causality of adverse events experienced.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
8.Secondary Outcome
Title Plasma Concentration of Soluble Vascular Endothelial Growth Factor Receptor 1 (s-VEGFR1)
Hide Description [Not Specified]
Time Frame Cycle 1 Day 1 predose, Day 1 of Cycle 2 to Cycle 7, and end of treatment/discontinuation (assessed up to 1709 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Biomarker analysis set included all participants enrolled in the study who received at least 1 dose of study medication and who submitted at least 1 sample; n=number of participants assessed.
Arm/Group Title AG-013736
Hide Arm/Group Description:
The starting dose of AG-013736 was 5 mg twice daily (BID), which was administered orally at approximately 12 hours apart in cycles of 4 weeks (28 days). The treatment is to be continued until the participants meet the discontinuation criteria such as disease progression or intolerable toxicity. The dose of AG-013736 could be titrated to 7 mg BID, and then 10 mg BID or reduced to 3 mg BID, and then 2 mg BID depending on the grade, type, and causality of adverse events experienced.
Overall Number of Participants Analyzed 64
Median (Full Range)
Unit of Measure: pg/mL
Cycle 1 Day 1 (n=64)
83.10
(44.3 to 215)
Cycle 2 Day 1 (n=63)
63.60
(0 to 190)
Cycle 3 Day 1 (n=60)
68.20
(36.4 to 936)
Cycle 4 Day 1 (n=59)
69.20
(33.5 to 119)
Cycle 5 Day 1 (n=57)
62.90
(0 to 125)
Cycle 6 Day 1 (n=52)
62.00
(32.1 to 119)
Cycle 7 Day 1 (n=48)
57.75
(0 to 101)
End of Treatment/Discontinuation (n=55)
76.60
(0 to 2780)
9.Secondary Outcome
Title Plasma Concentration of Soluble Vascular Endothelial Growth Factor Receptor 2 (s-VEGFR2)
Hide Description [Not Specified]
Time Frame Cycle 1 Day 1 predose, Day 1 of Cycle 2 to Cycle 7, and end of treatment/discontinuation (assessed up to 1709 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Biomarker analysis set included all participants enrolled in the study who received at least 1 dose of study medication and who submitted at least 1 sample; n=number of participants assessed.
Arm/Group Title AG-013736
Hide Arm/Group Description:
The starting dose of AG-013736 was 5 mg twice daily (BID), which was administered orally at approximately 12 hours apart in cycles of 4 weeks (28 days). The treatment is to be continued until the participants meet the discontinuation criteria such as disease progression or intolerable toxicity. The dose of AG-013736 could be titrated to 7 mg BID, and then 10 mg BID or reduced to 3 mg BID, and then 2 mg BID depending on the grade, type, and causality of adverse events experienced.
Overall Number of Participants Analyzed 64
Median (Full Range)
Unit of Measure: pg/mL
Cycle 1 Day 1 (n=64)
8900.0
(2620 to 13400)
Cycle 2 Day 1 (n=63)
6040.0
(2760 to 12600)
Cycle 3 Day 1 (n=60)
5980.0
(3340 to 11600)
Cycle 4 Day 1 (n=59)
6030.0
(3310 to 11600)
Cycle 5 Day 1 (n=57)
5880.0
(3140 to 10400)
Cycle 6 Day 1 (n=52)
5790.0
(3160 to 9920)
Cycle 7 Day 1 (n=48)
5395.0
(3620 to 10400)
End of Treatment/Discontinuation (n=55)
6540.0
(2870 to 12600)
10.Secondary Outcome
Title Plasma Concentration of Soluble Vascular Endothelial Growth Factor Receptor 3 (s-VEGFR3)
Hide Description [Not Specified]
Time Frame Cycle 1 Day 1 predose, Day 1 of Cycle 2 to Cycle 7, and end of treatment/discontinuation (assessed up to 1709 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Biomarker analysis set included all participants enrolled in the study who received at least 1 dose of study medication and who submitted at least 1 sample; n=number of participants assessed.
Arm/Group Title AG-013736
Hide Arm/Group Description:
The starting dose of AG-013736 was 5 mg twice daily (BID), which was administered orally at approximately 12 hours apart in cycles of 4 weeks (28 days). The treatment is to be continued until the participants meet the discontinuation criteria such as disease progression or intolerable toxicity. The dose of AG-013736 could be titrated to 7 mg BID, and then 10 mg BID or reduced to 3 mg BID, and then 2 mg BID depending on the grade, type, and causality of adverse events experienced.
Overall Number of Participants Analyzed 64
Median (Full Range)
Unit of Measure: pg/mL
Cycle 1 Day 1 (n=64)
20250.0
(2060 to 132000)
Cycle 2 Day 1 (n=63)
12000.0
(1990 to 45700)
Cycle 3 Day 1 (n=60)
13100.0
(2090 to 47700)
Cycle 4 Day 1 (n=59)
13800.0
(0 to 39100)
Cycle 5 Day 1 (n=57)
16700.0
(0 to 38100)
Cycle 6 Day 1 (n=52)
15550.0
(5200 to 39800)
Cycle 7 Day 1 (n=48)
13750.0
(0 to 38200)
End of Treatment/Discontinuation (n=55)
22300.0
(0 to 54500)
11.Secondary Outcome
Title Plasma Concentration of Soluble Stem Cell Factor Receptor (s-KIT)
Hide Description [Not Specified]
Time Frame Cycle 1 Day 1 predose, Day 1 of Cycle 2 to Cycle 7, and end of treatment/discontinuation (assessed up to 1709 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Biomarker analysis set included all participants enrolled in the study who received at least 1 dose of study medication and who submitted at least 1 sample; n=number of participants assessed.
Arm/Group Title AG-013736
Hide Arm/Group Description:
The starting dose of AG-013736 was 5 mg twice daily (BID), which was administered orally at approximately 12 hours apart in cycles of 4 weeks (28 days). The treatment is to be continued until the participants meet the discontinuation criteria such as disease progression or intolerable toxicity. The dose of AG-013736 could be titrated to 7 mg BID, and then 10 mg BID or reduced to 3 mg BID, and then 2 mg BID depending on the grade, type, and causality of adverse events experienced.
Overall Number of Participants Analyzed 64
Median (Full Range)
Unit of Measure: pg/mL
Cycle 1 Day 1 (n=64)
39050.0
(24800 to 73700)
Cycle 2 Day 1 (n=63)
35000.0
(21800 to 64000)
Cycle 3 Day 1 (n=60)
37300.0
(20700 to 65000)
Cycle 4 Day 1 (n=59)
38100.0
(20100 to 64300)
Cycle 5 Day 1 (n=57)
39800.0
(24600 to 70700)
Cycle 6 Day 1 (n=52)
41400.0
(23500 to 65900)
Cycle 7 Day 1 (n=48)
42400.0
(23100 to 62000)
End of Treatment/Discontinuation (n=55)
40600.0
(22200 to 72000)
12.Secondary Outcome
Title Plasma Concentration of Vascular Endothelial Growth Factor (VEGF)
Hide Description [Not Specified]
Time Frame Cycle 1 Day 1 predose, Day 1 of Cycle 2 to Cycle 7, and end of treatment/discontinuation (assessed up to 1709 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Biomarker analysis set included all participants enrolled in the study who received at least 1 dose of study medication and who submitted at least 1 sample; n=number of participants assessed.
Arm/Group Title AG-013736
Hide Arm/Group Description:
The starting dose of AG-013736 was 5 mg twice daily (BID), which was administered orally at approximately 12 hours apart in cycles of 4 weeks (28 days). The treatment is to be continued until the participants meet the discontinuation criteria such as disease progression or intolerable toxicity. The dose of AG-013736 could be titrated to 7 mg BID, and then 10 mg BID or reduced to 3 mg BID, and then 2 mg BID depending on the grade, type, and causality of adverse events experienced.
Overall Number of Participants Analyzed 64
Median (Full Range)
Unit of Measure: pg/mL
Cycle 1 Day 1 (n=64)
63.40
(26.4 to 361)
Cycle 2 Day 1 (n=63)
162.00
(31.5 to 856)
Cycle 3 Day 1 (n=60)
137.00
(26.3 to 723)
Cycle 4 Day 1 (n=59)
145.00
(21.9 to 514)
Cycle 5 Day 1 (n=57)
155.00
(24.3 to 554)
Cycle 6 Day 1 (n=52)
184.50
(21.3 to 743)
Cycle 7 Day 1 (n=48)
180.00
(46 to 762)
End of Treatment/Discontinuation (n=55)
121.00
(15.6 to 617)
13.Secondary Outcome
Title Number of Participants With Adverse Events
Hide Description Number of participants with any adverse events, adverse events graded as Common Terminology Criteria (CTCAE) for Adverse Events Version 3.0 Grade 3 or higher , serious adverse events, or adverse events resulted in discontinuation.
Time Frame Up to 1709 days of treatment plus 28-days follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
The Intent-To-Treat (ITT) population included all participants enrolled in the study who received at least 1 dose of study medication.
Arm/Group Title AG-013736
Hide Arm/Group Description:
The starting dose of AG-013736 was 5 mg twice daily (BID), which was administered orally at approximately 12 hours apart in cycles of 4 weeks (28 days). The treatment is to be continued until the participants meet the discontinuation criteria such as disease progression or intolerable toxicity. The dose of AG-013736 could be titrated to 7 mg BID, and then 10 mg BID or reduced to 3 mg BID, and then 2 mg BID depending on the grade, type, and causality of adverse events experienced.
Overall Number of Participants Analyzed 64
Measure Type: Number
Unit of Measure: participants
Any adverse events 64
Any serious adverse events 21
Any Grade-3 or -4 adverse events 58
Any Grade-5 adverse events (= death) 1
Discontinuation due to adverse events 16
Time Frame [Not Specified]
Adverse Event Reporting Description The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
 
Arm/Group Title AG-013736
Hide Arm/Group Description The starting dose of AG-013736 was 5 mg twice daily (BID), which was administered orally at approximately 12 hours apart in cycles of 4 weeks (28 days). The treatment is to be continued until the participants meet the discontinuation criteria such as disease progression or intolerable toxicity. The dose of AG-013736 could be titrated to 7 mg BID, and then 10 mg BID or reduced to 3 mg BID, and then 2 mg BID depending on the grade, type, and causality of adverse events experienced.
All-Cause Mortality
AG-013736
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
AG-013736
Affected / at Risk (%)
Total   21/64 (32.81%) 
Cardiac disorders   
Acute myocardial infarction * 1  1/64 (1.56%) 
Angina unstable * 1  1/64 (1.56%) 
Myocardial infarction * 1  1/64 (1.56%) 
Endocrine disorders   
Hyperthyroidism * 1  1/64 (1.56%) 
Gastrointestinal disorders   
Diarrhoea * 1  3/64 (4.69%) 
Duodenal stenosis * 1  1/64 (1.56%) 
Duodenal ulcer * 1  1/64 (1.56%) 
Gastrointestinal haemorrhage * 1  1/64 (1.56%) 
Peptic ulcer * 1  1/64 (1.56%) 
Upper gastrointestinal haemorrhage * 1  1/64 (1.56%) 
Vomiting * 1  2/64 (3.13%) 
General disorders   
Disease progression * 1  1/64 (1.56%) 
Malaise * 1  1/64 (1.56%) 
Hepatobiliary disorders   
Bile duct stone * 1  1/64 (1.56%) 
Cholecystitis * 1  1/64 (1.56%) 
Immune system disorders   
Anaphylactic reaction * 1  1/64 (1.56%) 
Infections and infestations   
Appendicitis * 1  1/64 (1.56%) 
Cryptococcosis * 1  1/64 (1.56%) 
Gastroenteritis * 1  1/64 (1.56%) 
Pneumonia * 1  2/64 (3.13%) 
Pyelonephritis * 1  1/64 (1.56%) 
Metabolism and nutrition disorders   
Decreased appetite * 1  1/64 (1.56%) 
Dehydration * 1  2/64 (3.13%) 
Hyponatraemia * 1  1/64 (1.56%) 
Nervous system disorders   
Balance disorder * 1  1/64 (1.56%) 
Leukoencephalopathy * 1  1/64 (1.56%) 
Loss of consciousness * 1  1/64 (1.56%) 
Subarachnoid haemorrhage * 1  1/64 (1.56%) 
Renal and urinary disorders   
Proteinuria * 1  1/64 (1.56%) 
Renal failure * 1  1/64 (1.56%) 
Respiratory, thoracic and mediastinal disorders   
Haemoptysis * 1  1/64 (1.56%) 
Pneumothorax * 1  1/64 (1.56%) 
Vascular disorders   
Hypertension * 1  2/64 (3.13%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 16.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
AG-013736
Affected / at Risk (%)
Total   64/64 (100.00%) 
Blood and lymphatic system disorders   
Anaemia * 1  5/64 (7.81%) 
Leukocytosis * 1  1/64 (1.56%) 
Lymphopenia * 1  1/64 (1.56%) 
Polycythaemia * 1  3/64 (4.69%) 
Cardiac disorders   
Angina pectoris * 1  1/64 (1.56%) 
Angina unstable * 1  1/64 (1.56%) 
Myocardial infarction * 1  1/64 (1.56%) 
Palpitations * 1  2/64 (3.13%) 
Sinus bradycardia * 1  1/64 (1.56%) 
Sinus tachycardia * 1  1/64 (1.56%) 
Tachycardia * 1  1/64 (1.56%) 
Ear and labyrinth disorders   
Deafness * 1  1/64 (1.56%) 
Ear discomfort * 1  3/64 (4.69%) 
Ear haemorrhage * 1  1/64 (1.56%) 
Ear pain * 1  3/64 (4.69%) 
External ear pain * 1  1/64 (1.56%) 
Hypoacusis * 1  1/64 (1.56%) 
Otorrhoea * 1  1/64 (1.56%) 
Tinnitus * 1  5/64 (7.81%) 
Vertigo * 1  1/64 (1.56%) 
Vertigo positional * 1  1/64 (1.56%) 
Endocrine disorders   
Adrenal insufficiency * 1  1/64 (1.56%) 
Hyperthyroidism * 1  2/64 (3.13%) 
Hypothyroidism * 1  31/64 (48.44%) 
Eye disorders   
Blepharitis * 1  1/64 (1.56%) 
Cataract * 1  1/64 (1.56%) 
Conjunctival haemorrhage * 1  1/64 (1.56%) 
Conjunctivitis * 1  1/64 (1.56%) 
Conjunctivitis allergic * 1  1/64 (1.56%) 
Dry eye * 1  2/64 (3.13%) 
Eye discharge * 1  2/64 (3.13%) 
Eye pain * 1  1/64 (1.56%) 
Eyelid oedema * 1  2/64 (3.13%) 
Eyelid pain * 1  1/64 (1.56%) 
Pinguecula * 1  1/64 (1.56%) 
Retinal haemorrhage * 1  1/64 (1.56%) 
Retinal tear * 1  1/64 (1.56%) 
Retinal vein occlusion * 1  1/64 (1.56%) 
Vision blurred * 1  2/64 (3.13%) 
Visual acuity reduced * 1  1/64 (1.56%) 
Gastrointestinal disorders   
Abdominal discomfort * 1  1/64 (1.56%) 
Abdominal distension * 1  1/64 (1.56%) 
Abdominal pain * 1  9/64 (14.06%) 
Abdominal pain lower * 1  1/64 (1.56%) 
Abdominal pain upper * 1  9/64 (14.06%) 
Anal fistula * 1  1/64 (1.56%) 
Anal pruritus * 1  1/64 (1.56%) 
Cheilitis * 1  6/64 (9.38%) 
Constipation * 1  14/64 (21.88%) 
Dental caries * 1  5/64 (7.81%) 
Diarrhoea * 1  44/64 (68.75%) 
Diarrhoea haemorrhagic * 1  1/64 (1.56%) 
Dry mouth * 1  3/64 (4.69%) 
Duodenal ulcer * 1  1/64 (1.56%) 
Dyspepsia * 1  5/64 (7.81%) 
Epigastric discomfort * 1  1/64 (1.56%) 
Faecal incontinence * 1  1/64 (1.56%) 
Gastric polyps * 1  1/64 (1.56%) 
Gastric ulcer * 1  1/64 (1.56%) 
Gastritis * 1  6/64 (9.38%) 
Gingival bleeding * 1  1/64 (1.56%) 
Gingival pain * 1  1/64 (1.56%) 
Gingival swelling * 1  1/64 (1.56%) 
Glossitis * 1  2/64 (3.13%) 
Glossodynia * 1  2/64 (3.13%) 
Haemorrhoidal haemorrhage * 1  1/64 (1.56%) 
Haemorrhoids * 1  4/64 (6.25%) 
Hypoaesthesia oral * 1  1/64 (1.56%) 
Ileus * 1  1/64 (1.56%) 
Nausea * 1  22/64 (34.38%) 
Oral pain * 1  2/64 (3.13%) 
Paraesthesia oral * 1  3/64 (4.69%) 
Perianal erythema * 1  1/64 (1.56%) 
Periodontal disease * 1  1/64 (1.56%) 
Stomatitis * 1  15/64 (23.44%) 
Tongue disorder * 1  1/64 (1.56%) 
Toothache * 1  2/64 (3.13%) 
Vomiting * 1  12/64 (18.75%) 
General disorders   
Chest discomfort * 1  3/64 (4.69%) 
Chest pain * 1  10/64 (15.63%) 
Chills * 1  2/64 (3.13%) 
Disease progression * 1  1/64 (1.56%) 
Face oedema * 1  4/64 (6.25%) 
Fatigue * 1  36/64 (56.25%) 
Gait disturbance * 1  1/64 (1.56%) 
Hypothermia * 1  2/64 (3.13%) 
Influenza like illness * 1  3/64 (4.69%) 
Local swelling * 1  1/64 (1.56%) 
Malaise * 1  9/64 (14.06%) 
Medical device complication * 1  1/64 (1.56%) 
Mucosal inflammation * 1  4/64 (6.25%) 
Oedema * 1  6/64 (9.38%) 
Oedema peripheral * 1  7/64 (10.94%) 
Pain * 1  2/64 (3.13%) 
Puncture site pain * 1  1/64 (1.56%) 
Pyrexia * 1  10/64 (15.63%) 
Thirst * 1  1/64 (1.56%) 
Ulcer * 1  1/64 (1.56%) 
Hepatobiliary disorders   
Alcoholic liver disease * 1  1/64 (1.56%) 
Cholelithiasis * 1  1/64 (1.56%) 
Hepatic function abnormal * 1  8/64 (12.50%) 
Hyperbilirubinaemia * 1  3/64 (4.69%) 
Liver disorder * 1  1/64 (1.56%) 
Immune system disorders   
Contrast media allergy * 1  1/64 (1.56%) 
Infections and infestations   
Acute sinusitis * 1  1/64 (1.56%) 
Adenoiditis * 1  1/64 (1.56%) 
Bacterial infection * 1  1/64 (1.56%) 
Cystitis * 1  4/64 (6.25%) 
Folliculitis * 1  1/64 (1.56%) 
Gastroenteritis * 1  4/64 (6.25%) 
Gastroenteritis viral * 1  2/64 (3.13%) 
Genital infection fungal * 1  1/64 (1.56%) 
Gingivitis * 1  4/64 (6.25%) 
Herpes zoster * 1  4/64 (6.25%) 
Hordeolum * 1  3/64 (4.69%) 
Infected dermal cyst * 1  1/64 (1.56%) 
Localised infection * 1  1/64 (1.56%) 
Nasopharyngitis * 1  25/64 (39.06%) 
Onychomycosis * 1  1/64 (1.56%) 
Otitis externa * 1  1/64 (1.56%) 
Otitis media * 1  1/64 (1.56%) 
Paronychia * 1  1/64 (1.56%) 
Periodontitis * 1  9/64 (14.06%) 
Pharyngitis * 1  1/64 (1.56%) 
Pulpitis dental * 1  1/64 (1.56%) 
Pyelonephritis * 1  1/64 (1.56%) 
Rhinitis * 1  2/64 (3.13%) 
Sinusitis * 1  3/64 (4.69%) 
Skin candida * 1  2/64 (3.13%) 
Tinea infection * 1  1/64 (1.56%) 
Tinea pedis * 1  2/64 (3.13%) 
Urinary tract infection * 1  1/64 (1.56%) 
Pneumonia * 1  1/64 (1.56%) 
Injury, poisoning and procedural complications   
Contusion * 1  1/64 (1.56%) 
Excoriation * 1  1/64 (1.56%) 
Fall * 1  6/64 (9.38%) 
Laceration * 1  1/64 (1.56%) 
Ligament injury * 1  1/64 (1.56%) 
Ligament sprain * 1  1/64 (1.56%) 
Post procedural complication * 1  1/64 (1.56%) 
Rib fracture * 1  1/64 (1.56%) 
Scratch * 1  1/64 (1.56%) 
Tooth injury * 1  1/64 (1.56%) 
Wound * 1  1/64 (1.56%) 
Wound complication * 1  1/64 (1.56%) 
Investigations   
Alanine aminotransferase increased * 1  15/64 (23.44%) 
Amylase increased * 1  2/64 (3.13%) 
Aspartate aminotransferase increased * 1  15/64 (23.44%) 
Blood albumin decreased * 1  7/64 (10.94%) 
Blood alkaline phosphatase increased * 1  13/64 (20.31%) 
Blood calcium decreased * 1  2/64 (3.13%) 
Blood chloride decreased * 1  1/64 (1.56%) 
Blood cholesterol increased * 1  1/64 (1.56%) 
Blood creatine phosphokinase increased * 1  1/64 (1.56%) 
Blood creatinine increased * 1  5/64 (7.81%) 
Blood lactate dehydrogenase increased * 1  8/64 (12.50%) 
Blood potassium increased * 1  2/64 (3.13%) 
Blood pressure decreased * 1  1/64 (1.56%) 
Blood sodium decreased * 1  2/64 (3.13%) 
Blood thyroid stimulating hormone decreased * 1  4/64 (6.25%) 
Blood thyroid stimulating hormone increased * 1  21/64 (32.81%) 
Blood urea decreased * 1  1/64 (1.56%) 
Blood urea increased * 1  6/64 (9.38%) 
Blood uric acid increased * 1  1/64 (1.56%) 
Blood urine present * 1  5/64 (7.81%) 
C-reactive protein increased * 1  7/64 (10.94%) 
Gamma-glutamyltransferase increased * 1  3/64 (4.69%) 
Haematocrit decreased * 1  1/64 (1.56%) 
Haemoglobin decreased * 1  5/64 (7.81%) 
International normalised ratio increased * 1  2/64 (3.13%) 
Liver function test abnormal * 1  1/64 (1.56%) 
Lymphocyte count decreased * 1  1/64 (1.56%) 
Neutrophil count decreased * 1  4/64 (6.25%) 
Platelet count decreased * 1  8/64 (12.50%) 
Protein total decreased * 1  1/64 (1.56%) 
Protein urine * 1  5/64 (7.81%) 
Protein urine present * 1  2/64 (3.13%) 
Prothrombin time shortened * 1  1/64 (1.56%) 
Red blood cell count decreased * 1  2/64 (3.13%) 
Red blood cell count increased * 1  1/64 (1.56%) 
Thyroxine free decreased * 1  3/64 (4.69%) 
Thyroxine free increased * 1  3/64 (4.69%) 
Tri-iodothyronine free decreased * 1  1/64 (1.56%) 
Tri-iodothyronine free increased * 1  3/64 (4.69%) 
Weight decreased * 1  21/64 (32.81%) 
White blood cell count decreased * 1  2/64 (3.13%) 
Metabolism and nutrition disorders   
Decreased appetite * 1  27/64 (42.19%) 
Dehydration * 1  1/64 (1.56%) 
Diabetes mellitus * 1  1/64 (1.56%) 
Gout * 1  1/64 (1.56%) 
Hypercholesterolaemia * 1  1/64 (1.56%) 
Hyperglycaemia * 1  1/64 (1.56%) 
Hyperkalaemia * 1  1/64 (1.56%) 
Hyperlipidaemia * 1  6/64 (9.38%) 
Hyperuricaemia * 1  3/64 (4.69%) 
Hypoalbuminaemia * 1  1/64 (1.56%) 
Hypokalaemia * 1  1/64 (1.56%) 
Hyponatraemia * 1  1/64 (1.56%) 
Musculoskeletal and connective tissue disorders   
Arthralgia * 1  15/64 (23.44%) 
Back pain * 1  13/64 (20.31%) 
Bone pain * 1  2/64 (3.13%) 
Chondrocalcinosis pyrophosphate * 1  1/64 (1.56%) 
Jaw cyst * 1  1/64 (1.56%) 
Musculoskeletal chest pain * 1  1/64 (1.56%) 
Musculoskeletal pain * 1  9/64 (14.06%) 
Musculoskeletal stiffness * 1  5/64 (7.81%) 
Myalgia * 1  4/64 (6.25%) 
Neck pain * 1  5/64 (7.81%) 
Osteoarthritis * 1  1/64 (1.56%) 
Osteonecrosis of jaw * 1  1/64 (1.56%) 
Pain in extremity * 1  2/64 (3.13%) 
Periarthritis * 1  1/64 (1.56%) 
Rheumatoid arthritis * 1  1/64 (1.56%) 
Trismus * 1  1/64 (1.56%) 
Pain in jaw * 1  1/64 (1.56%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Skin papilloma * 1  1/64 (1.56%) 
Tumour pain * 1  1/64 (1.56%) 
Nervous system disorders   
Altered state of consciousness * 1  1/64 (1.56%) 
Cerebral infarction * 1  1/64 (1.56%) 
Dizziness * 1  7/64 (10.94%) 
Dysgeusia * 1  12/64 (18.75%) 
Epilepsy * 1  1/64 (1.56%) 
Headache * 1  18/64 (28.13%) 
Hyperaesthesia * 1  1/64 (1.56%) 
Hypoaesthesia * 1  5/64 (7.81%) 
Neuropathy peripheral * 1  1/64 (1.56%) 
Parosmia * 1  1/64 (1.56%) 
Ataxia * 1  1/64 (1.56%) 
Psychiatric disorders   
Anxiety * 1  1/64 (1.56%) 
Insomnia * 1  4/64 (6.25%) 
Mood altered * 1  1/64 (1.56%) 
Panic disorder with agoraphobia * 1  1/64 (1.56%) 
Renal and urinary disorders   
Bladder irritation * 1  1/64 (1.56%) 
Haematuria * 1  1/64 (1.56%) 
Proteinuria * 1  33/64 (51.56%) 
Renal impairment * 1  2/64 (3.13%) 
Dysuria * 1  1/64 (1.56%) 
Reproductive system and breast disorders   
Genital tract inflammation * 1  1/64 (1.56%) 
Menstruation irregular * 1  2/64 (3.13%) 
Pelvic pain * 1  1/64 (1.56%) 
Scrotal haematocoele * 1  1/64 (1.56%) 
Respiratory, thoracic and mediastinal disorders   
Bronchiectasis * 1  1/64 (1.56%) 
Cough * 1  14/64 (21.88%) 
Dysphonia * 1  34/64 (53.13%) 
Dyspnoea * 1  3/64 (4.69%) 
Epistaxis * 1  17/64 (26.56%) 
Haemoptysis * 1  2/64 (3.13%) 
Hiccups * 1  2/64 (3.13%) 
Nasal inflammation * 1  3/64 (4.69%) 
Nasal mucosal disorder * 1  1/64 (1.56%) 
Oropharyngeal discomfort * 1  2/64 (3.13%) 
Oropharyngeal pain * 1  9/64 (14.06%) 
Pleural effusion * 1  1/64 (1.56%) 
Productive cough * 1  2/64 (3.13%) 
Respiratory disorder * 1  1/64 (1.56%) 
Rhinalgia * 1  1/64 (1.56%) 
Rhinorrhoea * 1  2/64 (3.13%) 
Sputum retention * 1  1/64 (1.56%) 
Upper respiratory tract inflammation * 1  4/64 (6.25%) 
Skin and subcutaneous tissue disorders   
Acne * 1  3/64 (4.69%) 
Alopecia * 1  5/64 (7.81%) 
Decubitus ulcer * 1  1/64 (1.56%) 
Dermal cyst * 1  1/64 (1.56%) 
Dermatitis * 1  3/64 (4.69%) 
Dry skin * 1  3/64 (4.69%) 
Eczema * 1  3/64 (4.69%) 
Eczema asteatotic * 1  1/64 (1.56%) 
Erythema * 1  2/64 (3.13%) 
Hair disorder * 1  1/64 (1.56%) 
Hyperkeratosis * 1  4/64 (6.25%) 
Nail disorder * 1  3/64 (4.69%) 
Palmar-plantar erythrodysaesthesia syndrome * 1  48/64 (75.00%) 
Penile ulceration * 1  1/64 (1.56%) 
Pruritus * 1  6/64 (9.38%) 
Rash * 1  17/64 (26.56%) 
Seborrhoeic dermatitis * 1  1/64 (1.56%) 
Skin exfoliation * 1  1/64 (1.56%) 
Skin hyperpigmentation * 1  2/64 (3.13%) 
Skin mass * 1  1/64 (1.56%) 
Skin ulcer * 1  1/64 (1.56%) 
Vascular disorders   
Hot flush * 1  1/64 (1.56%) 
Hypertension * 1  56/64 (87.50%) 
Hypotension * 1  1/64 (1.56%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 16.0
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
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00569946     History of Changes
Other Study ID Numbers: A4061035
First Submitted: December 7, 2007
First Posted: December 10, 2007
Results First Submitted: February 25, 2012
Results First Posted: March 27, 2012
Last Update Posted: June 5, 2019