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A Study of Bevacizumab (Avastin) in Combination With Capecitabine (Xeloda) in Elderly Patients With Metastatic Colorectal Cancer

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ClinicalTrials.gov Identifier: NCT00484939
Recruitment Status : Completed
First Posted : June 12, 2007
Results First Posted : June 10, 2014
Last Update Posted : January 8, 2015
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Colorectal Cancer
Interventions Drug: Bevacizumab
Drug: Capecitabine
Enrollment 280
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Bevacizumab + Capecitabine Capecitabine
Hide Arm/Group Description Participants received bevacizumab 7.5 mg/kg intravenously on Day 1 of each 3-week treatment cycle. In addition, participants received capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 3-week treatment cycle. Participants received capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 3-week treatment cycle.
Period Title: Overall Study
Started 140 140
Completed 0 0
Not Completed 140 140
Reason Not Completed
Death             9             13
Adverse Event             22             12
Patient Withdrew Consent             19             10
Protocol Violation             3             3
Lost to Follow-up             0             3
Discretion of Investigator or Sponsor             7             3
Disease progression             67             88
Screen Failure             2             2
Reason Not Specified             11             6
Arm/Group Title Bevacizumab + Capecitabine Capecitabine Total
Hide Arm/Group Description Participants received bevacizumab 7.5 mg/kg intravenously on Day 1 of each 3-week treatment cycle. In addition, participants received capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 3-week treatment cycle. Participants received capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 3-week treatment cycle. Total of all reporting groups
Overall Number of Baseline Participants 140 140 280
Hide Baseline Analysis Population Description
Intent-to-treat population: All participants randomized into the study.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 140 participants 140 participants 280 participants
76.1  (4.18) 76.5  (3.91) 76.3  (4.04)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 140 participants 140 participants 280 participants
Female
56
  40.0%
56
  40.0%
112
  40.0%
Male
84
  60.0%
84
  60.0%
168
  60.0%
1.Primary Outcome
Title Progression-free Survival
Hide Description Progression-free survival was defined as the time in months from the date of randomization to the date of disease progression or death from any cause, whichever occurred first. All measurable lesions (maximum of 5 per organ and 10 in total, those with the longest diameter and suitability for accurate repeated measurements) were identified as target lesions (TL). A sum of the longest diameter for all TLs was calculated and reported as the baseline sum longest diameter (SLD). All other lesions were identified as non-TLs and recorded at baseline. PD was defined as ≥ 20% increase in the sum of the longest diameter of TLs, taking as reference the smallest SLD recorded since treatment started, the unequivocal progression of existing non-TLs, or the appearance of 1 or more new lesions.
Time Frame Baseline to the end of the study (up to 5 years 8 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population: All participants randomized into the study.
Arm/Group Title Bevacizumab + Capecitabine Capecitabine
Hide Arm/Group Description:
Participants received bevacizumab 7.5 mg/kg intravenously on Day 1 of each 3-week treatment cycle. In addition, participants received capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 3-week treatment cycle.
Participants received capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 3-week treatment cycle.
Overall Number of Participants Analyzed 140 140
Median (95% Confidence Interval)
Unit of Measure: Months
9.1
(7.3 to 11.3)
5.1
(4.3 to 6.3)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Bevacizumab + Capecitabine, Capecitabine
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 [Not Specified]
2.Secondary Outcome
Title Best Overall Response (BOR)
Hide Description BOR was defined as the best response (complete response [CR], partial response [PR], stable disease [SD], progressive disease [PD], not evaluable [NE], or not assessed [NA]) recorded from the start of study treatment until disease progression (PD) or death. CR was defined as the disappearance of all target (TL) and non-target lesions (non-TL). PR was defined as ≥ 30% decrease in the sum of the longest diameter (SLD) of TLs, taking as reference the baseline SLD, or the persistence of 1 or more non-TLs. For TLs, SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest SLD since treatment started. For non-TLs, SD was defined as the persistence of 1 or more lesions. PD was defined as ≥ 20% increase in the sum of the longest diameter of TLs, taking as reference the smallest SLD recorded since treatment started, the unequivocal progression of existing non-TLs, or the appearance of 1 or more new lesions.
Time Frame Baseline to the end of the study (up to 5 years 8 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population: All participants randomized into the study. Only participants with a response were included in the analysis.
Arm/Group Title Bevacizumab + Capecitabine Capecitabine
Hide Arm/Group Description:
Participants received bevacizumab 7.5 mg/kg intravenously on Day 1 of each 3-week treatment cycle. In addition, participants received capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 3-week treatment cycle.
Participants received capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 3-week treatment cycle.
Overall Number of Participants Analyzed 140 140
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
Complete Response
2.9
(0.8 to 7.2)
1.4
(0.2 to 5.1)
Partial Response
17.1
(11.3 to 24.4)
8.6
(4.5 to 14.5)
Stable Disease
54.3
(45.7 to 62.7)
48.6
(40.0 to 57.2)
Progressive Disease
10.0
(5.6 to 16.2)
21.4
(14.9 to 29.2)
Not assessed
15.7
(10.1 to 22.8)
20.0
(13.7 to 27.6)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Bevacizumab + Capecitabine, Capecitabine
Comments This statistical analysis compared the number of responders in the 2 treatment groups. A responder was defined as any participant with a best overall response of complete response or partial response. There were 28 responders in the bevacizumab + capecitabine group and 14 responders in the capecitabine group.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.029
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
3.Secondary Outcome
Title Duration of Response
Hide Description Duration of response was defined as the time in months from the first confirmed complete response (CR) or partial response (PR) until disease progression or death from any cause, whichever occurred first. CR was defined as the disappearance of all target (TL) and non-target lesions (non-TL). PR was defined as ≥ 30% decrease in the sum of the longest diameter (SLD) of TLs, taking as reference the baseline SLD, or the persistence of 1 or more non-TLs.
Time Frame Baseline to the end of the study (up to 5 years 8 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population: All participants randomized into the study. Only participants with a complete response or partial response were included in the analysis.
Arm/Group Title Bevacizumab + Capecitabine Capecitabine
Hide Arm/Group Description:
Participants received bevacizumab 7.5 mg/kg intravenously on Day 1 of each 3-week treatment cycle. In addition, participants received capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 3-week treatment cycle.
Participants received capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 3-week treatment cycle.
Overall Number of Participants Analyzed 28 14
Median (95% Confidence Interval)
Unit of Measure: Months
9.7
(8.3 to 10.9)
9.4
(6.2 to 12.6)
4.Secondary Outcome
Title Time to Response
Hide Description Time to response was defined as the time in months from the date of first study treatment to the date of the first documentation of complete response (CR) or partial response (PR), whichever occurred first. CR was defined as the disappearance of all target (TL) and non-target lesions (non-TL). PR was defined as ≥ 30% decrease in the sum of the longest diameter (SLD) of TLs, taking as reference the baseline SLD, or the persistence of 1 or more non-TLs. Participants who did not have a confirmed response were censored at the date of the last evaluable tumor assessment, or if that was unavailable, at the date of the first dose of study medication.
Time Frame Baseline to the end of the study (up to 5 years 8 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population: All participants randomized into the study.
Arm/Group Title Bevacizumab + Capecitabine Capecitabine
Hide Arm/Group Description:
Participants received bevacizumab 7.5 mg/kg intravenously on Day 1 of each 3-week treatment cycle. In addition, participants received capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 3-week treatment cycle.
Participants received capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 3-week treatment cycle.
Overall Number of Participants Analyzed 140 140
Median (95% Confidence Interval)
Unit of Measure: Months
NA [1] 
(NA to NA)
NA [2] 
(30.4 to NA)
[1]
The median and the lower and upper limits of the 95% confidence interval could not be calculated due to insufficient data.
[2]
The median and the upper limit of the 95% confidence interval could not be calculated due to insufficient data.
5.Secondary Outcome
Title Overall Survival
Hide Description Overall survival was defined as the time in months from randomization to death from any cause.
Time Frame Baseline to the end of the study (up to 5 years 8 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population: All participants randomized into the study.
Arm/Group Title Bevacizumab + Capecitabine Capecitabine
Hide Arm/Group Description:
Participants received bevacizumab 7.5 mg/kg intravenously on Day 1 of each 3-week treatment cycle. In addition, participants received capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 3-week treatment cycle.
Participants received capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 3-week treatment cycle.
Overall Number of Participants Analyzed 140 140
Median (95% Confidence Interval)
Unit of Measure: Months
20.7
(16.6 to 26.0)
17.0
(12.9 to 22.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Bevacizumab + Capecitabine, Capecitabine
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.130
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
6.Secondary Outcome
Title Eastern Cooperative Oncology Group (ECOG) Performance Status
Hide Description The ECOG performance status is a scale used to quantify cancer patients' general well-being and activities of daily life. The scale ranges from 0 to 5, with 0 denoting perfect health and 5 indicating death. The 6 categories are 0=Asymptomatic (Fully active, able to carry on all predisease activities without restriction), 1=Symptomatic but completely ambulatory (Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature), 2=Symptomatic, < 50% in bed during the day (Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours), 3=Symptomatic, > 50% in bed, but not bedbound (Capable of only limited self-care, confined to bed or chair 50% or more of waking hours), 4=Bedbound (Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair), 5=Death. Reported is the percentage of participants in each of the 6 ECOG performance status categories.
Time Frame Baseline to the Safety Follow-up which occurred 28 days after the last dose of treatment (up to 5 years 8 months).
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population: All participants randomized into the study.
Arm/Group Title Bevacizumab + Capecitabine Capecitabine
Hide Arm/Group Description:
Participants received bevacizumab 7.5 mg/kg intravenously on Day 1 of each 3-week treatment cycle. In addition, participants received capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 3-week treatment cycle.
Participants received capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 3-week treatment cycle.
Overall Number of Participants Analyzed 140 140
Measure Type: Number
Unit of Measure: Percentage of participants
Week 7 ECOG = 0 (n=117,110) 50.4 34.5
Week 7 ECOG = 1 47.0 58.2
Week 7 ECOG = 2 1.7 5.5
Week 7 ECOG = 3 0.9 1.8
Week 7 ECOG = 4 0.0 0.0
Week 7 ECOG = 5 0.0 0.0
Week 16 ECOG = 0 (n=88,77) 50.0 36.4
Week 16 ECOG = 1 45.5 51.9
Week 16 ECOG = 2 3.4 11.7
Week 16 ECOG = 3 1.1 0.0
Week 16 ECOG = 4 0.0 0.0
Week 16 ECOG = 5 0.0 0.0
Week 25 ECOG = 0 (n=66,42) 43.9 45.2
Week 25 ECOG = 1 48.5 45.2
Week 25 ECOG = 2 6.1 9.5
Week 25 ECOG = 3 1.5 0.0
Week 25 ECOG = 4 0.0 0.0
Week 25 ECOG = 5 0.0 0.0
Week 34 ECOG = 0 (n=48,24) 39.6 33.3
Week 34 ECOG = 1 58.3 58.3
Week 34 ECOG = 2 0.0 8.3
Week 34 ECOG = 3 2.1 0.0
Week 34 ECOG = 4 0.0 0.0
Week 34 ECOG = 5 0.0 0.0
Safety Follow-up ECOG = 0 (n=89,82) 33.7 32.9
Safety Follow-up ECOG = 1 47.2 45.1
Safety Follow-up ECOG = 2 12.4 14.6
Safety Follow-up ECOG = 3 6.7 4.9
Safety Follow-up ECOG = 4 0.0 1.2
Safety Follow-up ECOG = 5 0.0 1.2
7.Secondary Outcome
Title Percentage of Participants Requiring Additional Treatment for Malignancy
Hide Description Reported is the percentage of participants requiring additional treatment for malignancy in the survival follow-up period.
Time Frame Baseline to the end of the study (up to 5 years 8 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population: All participants randomized into the study.
Arm/Group Title Bevacizumab + Capecitabine Capecitabine
Hide Arm/Group Description:
Participants received bevacizumab 7.5 mg/kg intravenously on Day 1 of each 3-week treatment cycle. In addition, participants received capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 3-week treatment cycle.
Participants received capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 3-week treatment cycle.
Overall Number of Participants Analyzed 140 140
Measure Type: Number
Unit of Measure: Percentage of participants
50.7 49.3
8.Secondary Outcome
Title Duration of Follow-up
Hide Description Duration of follow-up is defined as the time in days from randomization until disease progression or death, or time to censoring for overall survival.
Time Frame Baseline to the end of the study (up to 5 years 8 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population: All participants randomized into the study.
Arm/Group Title Bevacizumab + Capecitabine Capecitabine
Hide Arm/Group Description:
Participants received bevacizumab 7.5 mg/kg intravenously on Day 1 of each 3-week treatment cycle. In addition, participants received capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 3-week treatment cycle.
Participants received capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 3-week treatment cycle.
Overall Number of Participants Analyzed 140 140
Mean (Standard Deviation)
Unit of Measure: Days
540.5  (423.52) 479.2  (401.01)
9.Secondary Outcome
Title AEs, Laboratory Parameters, Vital Signs
Hide Description [Not Specified]
Time Frame Throughout study
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description Safety population: All participants who had at least 1 dose of study medication.
 
Arm/Group Title Bevacizumab + Capecitabine Capecitabine
Hide Arm/Group Description Participants received bevacizumab 7.5 mg/kg intravenously on Day 1 of each 3-week treatment cycle. In addition, participants received capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 3-week treatment cycle. Participants received capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 3-week treatment cycle.
All-Cause Mortality
Bevacizumab + Capecitabine Capecitabine
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Bevacizumab + Capecitabine Capecitabine
Affected / at Risk (%) Affected / at Risk (%)
Total   40/134 (29.85%)   42/136 (30.88%) 
Blood and lymphatic system disorders     
Anaemia † 1  0/134 (0.00%)  1/136 (0.74%) 
Neutropenia † 1  0/134 (0.00%)  1/136 (0.74%) 
Cardiac disorders     
Cardiac arrest † 1  1/134 (0.75%)  2/136 (1.47%) 
Angina pectoris † 1  1/134 (0.75%)  1/136 (0.74%) 
Myocardial infarction † 1  1/134 (0.75%)  0/136 (0.00%) 
Myocardial ischaemia † 1  1/134 (0.75%)  0/136 (0.00%) 
Cardiac failure † 1  0/134 (0.00%)  1/136 (0.74%) 
Eye disorders     
Amaurosis fugax † 1  1/134 (0.75%)  0/136 (0.00%) 
Gastrointestinal disorders     
Abdominal pain † 1  3/134 (2.24%)  4/136 (2.94%) 
Intestinal obstruction † 1  3/134 (2.24%)  4/136 (2.94%) 
Vomiting † 1  2/134 (1.49%)  2/136 (1.47%) 
Abdominal discomfort † 1  1/134 (0.75%)  0/136 (0.00%) 
Haematochezia † 1  1/134 (0.75%)  0/136 (0.00%) 
Inguinal hernia † 1  1/134 (0.75%)  0/136 (0.00%) 
Nausea † 1  1/134 (0.75%)  0/136 (0.00%) 
Small intestinal obstruction † 1  1/134 (0.75%)  0/136 (0.00%) 
Diarrhoea † 1  0/134 (0.00%)  4/136 (2.94%) 
Ascites † 1  0/134 (0.00%)  3/136 (2.21%) 
Colonic obstruction † 1  0/134 (0.00%)  1/136 (0.74%) 
Mechanical ileus † 1  0/134 (0.00%)  1/136 (0.74%) 
Upper gastrointestinal haemorrhage † 1  0/134 (0.00%)  1/136 (0.74%) 
General disorders     
Pyrexia † 1  3/134 (2.24%)  2/136 (1.47%) 
General physical health deterioration † 1  1/134 (0.75%)  2/136 (1.47%) 
Pain † 1  1/134 (0.75%)  1/136 (0.74%) 
Death † 1  1/134 (0.75%)  0/136 (0.00%) 
Oedema † 1  1/134 (0.75%)  0/136 (0.00%) 
Asthenia † 1  0/134 (0.00%)  1/136 (0.74%) 
Fatigue † 1  0/134 (0.00%)  1/136 (0.74%) 
Hepatobiliary disorders     
Jaundice † 1  0/134 (0.00%)  2/136 (1.47%) 
Hepatic failure † 1  0/134 (0.00%)  1/136 (0.74%) 
Hepatitis acute † 1  0/134 (0.00%)  1/136 (0.74%) 
Infections and infestations     
Pneumonia † 1  3/134 (2.24%)  1/136 (0.74%) 
Bronchitis † 1  1/134 (0.75%)  0/136 (0.00%) 
Escherichia urinary tract infection † 1  1/134 (0.75%)  0/136 (0.00%) 
Lower respiratory tract infection † 1  1/134 (0.75%)  0/136 (0.00%) 
Pneumonia bacterial † 1  1/134 (0.75%)  0/136 (0.00%) 
Pulmonary sepsis † 1  1/134 (0.75%)  0/136 (0.00%) 
Urosepsis † 1  1/134 (0.75%)  0/136 (0.00%) 
Cellulitis gangrenous † 1  0/134 (0.00%)  1/136 (0.74%) 
Gastroenteritis † 1  0/134 (0.00%)  1/136 (0.74%) 
Sepsis † 1  0/134 (0.00%)  1/136 (0.74%) 
Injury, poisoning and procedural complications     
Excoriation † 1  1/134 (0.75%)  0/136 (0.00%) 
Impacted fracture † 1  1/134 (0.75%)  0/136 (0.00%) 
Patella fracture † 1  1/134 (0.75%)  0/136 (0.00%) 
Spinal compression fracture † 1  1/134 (0.75%)  0/136 (0.00%) 
Metabolism and nutrition disorders     
Dehydration † 1  1/134 (0.75%)  1/136 (0.74%) 
Decreased appetite † 1  0/134 (0.00%)  2/136 (1.47%) 
Musculoskeletal and connective tissue disorders     
Groin pain † 1  1/134 (0.75%)  0/136 (0.00%) 
Neck pain † 1  0/134 (0.00%)  1/136 (0.74%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Metastatic neoplasm † 1  1/134 (0.75%)  1/136 (0.74%) 
Metastases to lung † 1  0/134 (0.00%)  1/136 (0.74%) 
Nervous system disorders     
Transient ischaemic attack † 1  1/134 (0.75%)  1/136 (0.74%) 
Amnesia † 1  1/134 (0.75%)  0/136 (0.00%) 
Cerebral ischaemia † 1  1/134 (0.75%)  0/136 (0.00%) 
Lethargy † 1  1/134 (0.75%)  0/136 (0.00%) 
Somnolence † 1  1/134 (0.75%)  0/136 (0.00%) 
Renal and urinary disorders     
Calculus ureteric † 1  1/134 (0.75%)  1/136 (0.74%) 
Renal failure † 1  0/134 (0.00%)  1/136 (0.74%) 
Reproductive system and breast disorders     
Female genital tract fistula † 1  1/134 (0.75%)  0/136 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Pulmonary embolism † 1  8/134 (5.97%)  2/136 (1.47%) 
Pleural effusion † 1  1/134 (0.75%)  1/136 (0.74%) 
Dyspnoea † 1  0/134 (0.00%)  1/136 (0.74%) 
Skin and subcutaneous tissue disorders     
Rash macular † 1  1/134 (0.75%)  0/136 (0.00%) 
Surgical and medical procedures     
Bone operation † 1  0/134 (0.00%)  1/136 (0.74%) 
Vascular disorders     
Hypertension † 1  2/134 (1.49%)  1/136 (0.74%) 
Thrombosis † 1  2/134 (1.49%)  0/136 (0.00%) 
Deep vein thrombosis † 1  0/134 (0.00%)  3/136 (2.21%) 
Circulatory collapse † 1  0/134 (0.00%)  1/136 (0.74%) 
Peripheral artery thrombosis † 1  0/134 (0.00%)  1/136 (0.74%) 
Vena cava thrombosis † 1  0/134 (0.00%)  1/136 (0.74%) 
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (12.1)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Bevacizumab + Capecitabine Capecitabine
Affected / at Risk (%) Affected / at Risk (%)
Total   129/134 (96.27%)   130/136 (95.59%) 
Blood and lymphatic system disorders     
Neutropenia † 1  7/134 (5.22%)  2/136 (1.47%) 
Gastrointestinal disorders     
Diarrhoea † 1  54/134 (40.30%)  48/136 (35.29%) 
Nausea † 1  32/134 (23.88%)  37/136 (27.21%) 
Abdominal pain † 1  31/134 (23.13%)  21/136 (15.44%) 
Vomiting † 1  28/134 (20.90%)  16/136 (11.76%) 
Constipation † 1  25/134 (18.66%)  19/136 (13.97%) 
Stomatitis † 1  14/134 (10.45%)  14/136 (10.29%) 
Abdominal pain upper † 1  11/134 (8.21%)  5/136 (3.68%) 
Dyspepsia † 1  9/134 (6.72%)  4/136 (2.94%) 
General disorders     
Fatigue † 1  32/134 (23.88%)  37/136 (27.21%) 
Asthenia † 1  30/134 (22.39%)  22/136 (16.18%) 
Pyrexia † 1  24/134 (17.91%)  16/136 (11.76%) 
Mucosal inflammation † 1  20/134 (14.93%)  11/136 (8.09%) 
Oedema peripheral † 1  11/134 (8.21%)  17/136 (12.50%) 
Pain † 1  11/134 (8.21%)  6/136 (4.41%) 
Metabolism and nutrition disorders     
Decreased Appetite † 1  38/134 (28.36%)  31/136 (22.79%) 
Musculoskeletal and connective tissue disorders     
Back pain † 1  13/134 (9.70%)  11/136 (8.09%) 
Arthralgia † 1  12/134 (8.96%)  4/136 (2.94%) 
Pain in extremity † 1  11/134 (8.21%)  5/136 (3.68%) 
Musculoskeletal pain † 1  10/134 (7.46%)  4/136 (2.94%) 
Nervous system disorders     
Lethargy † 1  12/134 (8.96%)  15/136 (11.03%) 
Headache † 1  10/134 (7.46%)  5/136 (3.68%) 
Dizziness † 1  9/134 (6.72%)  17/136 (12.50%) 
Dysgeusia † 1  8/134 (5.97%)  6/136 (4.41%) 
Paraesthesia † 1  8/134 (5.97%)  1/136 (0.74%) 
Psychiatric disorders     
Insomnia † 1  7/134 (5.22%)  7/136 (5.15%) 
Renal and urinary disorders     
Proteinuria † 1  10/134 (7.46%)  1/136 (0.74%) 
Respiratory, thoracic and mediastinal disorders     
Epistaxis † 1  23/134 (17.16%)  5/136 (3.68%) 
Cough † 1  15/134 (11.19%)  12/136 (8.82%) 
Dyspnoea † 1  12/134 (8.96%)  13/136 (9.56%) 
Pulmonary embolism † 1  9/134 (6.72%)  2/136 (1.47%) 
Rhinorrhoea † 1  8/134 (5.97%)  1/136 (0.74%) 
Skin and subcutaneous tissue disorders     
Palmar-Plantar erythrodysaesthesia syndrome † 1  66/134 (49.25%)  54/136 (39.71%) 
Skin hyperpigmentation † 1  11/134 (8.21%)  2/136 (1.47%) 
Dry skin † 1  8/134 (5.97%)  4/136 (2.94%) 
Rash † 1  6/134 (4.48%)  12/136 (8.82%) 
Vascular disorders     
Hypertension † 1  22/134 (16.42%)  6/136 (4.41%) 
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (12.1)
[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.
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Medical Communications
Organization: Hoffmann-La Roche
Phone: 800 821-8590
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00484939    
Other Study ID Numbers: MO19286
First Submitted: June 11, 2007
First Posted: June 12, 2007
Results First Submitted: March 7, 2014
Results First Posted: June 10, 2014
Last Update Posted: January 8, 2015