Combination Chemotherapy With or Without Bevacizumab in Treating Patients Who Have Undergone Surgery for High Risk Stage II or Stage III Colon Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00112918
First received: June 2, 2005
Last updated: June 19, 2013
Last verified: June 2013
Results First Received: June 1, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Colorectal Cancer
Interventions: Biological: Bevacizumab
Drug: Capecitabine
Drug: 5-Fluorouracil (5-FU)
Drug: Leucovorin calcium
Drug: Oxaliplatin

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Randomization was stratified according to geographic region and disease stage (high-risk stage II or stage III N1 or stage III N2). The primary analysis population consisted of patients with Stage III disease.

Reporting Groups
  Description
FOLFOX4

Weeks 1-24: Oxaliplatin was administered as an 85 mg/m^2 intravenous infusion over 2 hours concomitantly with leucovorin as a 200 mg/m^2 infusion over 2 hours, followed by 5-fluorouracil (5-FU), given as a 400 mg/m^2 bolus injection, and then as a 600 mg/m^2 continuous infusion over 22 hours. Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection, and 5-FU 600 mg/m^2 continuous infusion were repeated on day 2. Cycle length was 2 weeks and cycles were repeated every second week for a total of 12 cycles (24 weeks).

Weeks 25-48: Observation only.

FOLFOX4 + Bv

Weeks 1-24: Bevacizumab 5 mg/kg was administered as an intravenous infusion over 30 - 90 minutes followed by oxaliplatin, administered as an 85 mg/m^2 intravenous infusion over 2 hours (on day 1 only) concomitantly with leucovorin, as a 200 mg/m^2 infusion over 2 hours, followed by 5-FU, given as a 400 mg/m^2 bolus injection, and then as a 600 mg/m^2 continuous infusion over 22 hours. Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection, and 5-FU 600 mg/m^2 continuous infusion are repeated on day 2. Cycle length is 2 weeks and cycles were repeated every second week for a total of 12 cycles (24 weeks).

Weeks 25-48: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 minutes. Cycle length was 3 weeks. Cycles were repeated every 3 weeks for a total of 8 cycles (24 weeks).

XELOX+Bv

Weeks 1-24: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 - 90 minutes followed by oxaliplatin administered as a 130 mg/m^2 intravenous infusion over 2 hours (day 1 every 3 weeks) in combination with capecitabine, which was administered orally at a dose of 1000 mg/m^2 twice daily (equivalent to a total daily dose of 2000 mg/m^2), with first dose the evening of day 1 and last dose the morning of day 15, given as intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment), for a total of 8 cycles (24 weeks).

Weeks 25-48: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 minutes. Cycle length was 3 weeks. Cycles were repeated every 3 weeks for a total of 8 cycles (24 weeks).


Participant Flow:   Overall Study
    FOLFOX4     FOLFOX4 + Bv     XELOX+Bv  
STARTED     1151     1155     1145  
Received Treatment     1126     1145 [1]   1135  
Stage III Disease Population     955     960     952  
COMPLETED     854 [2]   810 [2]   846 [2]
NOT COMPLETED     297     345     299  
[1] Includes two patients from FOLFOX4 who received Bv and were assigned to FOLFOX4+Bv safety analysis
[2] Represents patients alive in follow-up at the time of final data cut-off (30 June 2012)



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Baseline Measures are based on the Intent-to-Treat - Stage III Disease Patient Population.

Reporting Groups
  Description
FOLFOX4

Weeks 1-24: Oxaliplatin was administered as an 85 mg/m^2 intravenous infusion over 2 hours concomitantly with leucovorin as a 200 mg/m^2 infusion over 2 hours, followed by 5-fluorouracil (5-FU), given as a 400 mg/m^2 bolus injection, and then as a 600 mg/m^2 continuous infusion over 22 hours. Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection, and 5-FU 600 mg/m^2 continuous infusion were repeated on day 2. Cycle length was 2 weeks and cycles were repeated every second week for a total of 12 cycles (24 weeks).

Weeks 25-48: Observation only.

FOLFOX4 + Bv

Weeks 1–24: Bevacizumab 5 mg/kg was administered as an intravenous infusion over 30 – 90 minutes followed by oxaliplatin, administered as an 85 mg/m^2 intravenous infusion over 2 hours (on day 1 only) concomitantly with leucovorin, as a 200 mg/m^2 infusion over 2 hours, followed by 5-FU, given as a 400 mg/m^2 bolus injection, and then as a 600 mg/m^2 continuous infusion over 22 hours. Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection, and 5-FU 600 mg/m^2 continuous infusion are repeated on day 2. Cycle length is 2 weeks and cycles were repeated every second week for a total of 12 cycles (24 weeks).

Weeks 25–48: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 minutes. Cycle length was 3 weeks. Cycles were repeated every 3 weeks for a total of 8 cycles (24 weeks).

XELOX+Bv

Weeks 1–24: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 – 90 minutes followed by oxaliplatin administered as a 130 mg/m^2 intravenous infusion over 2 hours (day 1 every 3 weeks) in combination with capecitabine, which was administered orally at a dose of 1000 mg/m^2 twice daily (equivalent to a total daily dose of 2000 mg/m^2), with first dose the evening of day 1 and last dose the morning of day 15, given as intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment), for a total of 8 cycles (24 weeks).

Weeks 25–48: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 minutes. Cycle length was 3 weeks. Cycles were repeated every 3 weeks for a total of 8 cycles (24 weeks).

Total Total of all reporting groups

Baseline Measures
    FOLFOX4     FOLFOX4 + Bv     XELOX+Bv     Total  
Number of Participants  
[units: participants]
  955     960     952     2867  
Age, Customized  
[units: participants]
       
<40     77     74     68     219  
40-65     603     625     588     1816  
>=65     275     261     296     832  
Gender  
[units: participants]
       
Female     425     473     432     1330  
Male     530     487     520     1537  
Race/Ethnicity, Customized  
[units: participants]
       
American Indian or Alaska Native     1     1     0     2  
Asian     139     115     123     377  
Black or African American     6     13     14     33  
White     791     813     795     2399  
Other     18     18     20     56  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Disease-free Survival in Stage III Cancer Patients - Time to Event   [ Time Frame: From first patient randomized until the data cut-off date of 30 June 2010 (36 months after the last patient randomized). ]
  Hide Outcome Measure 1

Measure Type Primary
Measure Title Disease-free Survival in Stage III Cancer Patients - Time to Event
Measure Description Disease-free survival (DFS) was defined as the time from the date of randomization to the time of a recurrence, a new occurrence of colorectal cancer or death due to any cause, whichever occurred first. Patients without an event were censored at the last date the patient was known to be disease-free. Recurrence and new occurrence of colorectal cancer were based on tumor assessments made by the investigator. Patients with no tumor assessments after baseline but still alive at the time of the clinical cut-off were censored at day 1.
Time Frame From first patient randomized until the data cut-off date of 30 June 2010 (36 months after the last patient randomized).  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The primary population for efficacy analyses was the intent to treat population (ITT; all randomized patients) with stage III disease.

Reporting Groups
  Description
FOLFOX4

Weeks 1-24: Oxaliplatin was administered as an 85 mg/m^2 intravenous infusion over 2 hours concomitantly with leucovorin as a 200 mg/m^2 infusion over 2 hours, followed by 5-FU, given as a 400 mg/m^2 bolus injection, and then as a 600 mg/m^2 continuous infusion over 22 hours. Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection, and 5-FU 600 mg/m^2 continuous infusion were repeated on day 2. Cycle length was 2 weeks and cycles were repeated every second week for a total of 12 cycles (24 weeks).

Weeks 25-48: Observation only.

FOLFOX4 + Bv

Weeks 1-24: Bevacizumab 5 mg/kg was administered as an intravenous infusion over 30 - 90 minutes followed by oxaliplatin, administered as an 85 mg/m^2 intravenous infusion over 2 hours (on day 1 only) concomitantly with leucovorin, as a 200 mg/m^2 infusion over 2 hours, followed by 5-FU, given as a 400 mg/m^2 bolus injection, and then as a 600 mg/m^2 continuous infusion over 22 hours. Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection, and 5-FU 600 mg/m^2 continuous infusion are repeated on day 2. Cycle length is 2 weeks and cycles were repeated every second week for a total of 12 cycles (24 weeks).

Weeks 25-48: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 minutes. Cycle length was 3 weeks. Cycles were repeated every 3 weeks for a total of 8 cycles (24 weeks).

XELOX+Bv

Weeks 1-24: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 - 90 minutes followed by oxaliplatin administered as a 130 mg/m^2 intravenous infusion over 2 hours (day 1 every 3 weeks) in combination with capecitabine, which was administered orally at a dose of 1000 mg/m^2 twice daily (equivalent to a total daily dose of 2000 mg/m^2), with first dose the evening of day 1 and last dose the morning of day 15, given as intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment), for a total of 8 cycles (24 weeks).

Weeks 25-48: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 minutes. Cycle length was 3 weeks. Cycles were repeated every 3 weeks for a total of 8 cycles (24 weeks).


Measured Values
    FOLFOX4     FOLFOX4 + Bv     XELOX+Bv  
Number of Participants Analyzed  
[units: participants]
  955     960     952  
Disease-free Survival in Stage III Cancer Patients - Time to Event  
[units: months]
Median ( 95% Confidence Interval )
  NA  
  ( NA to NA ) [1]
  NA  
  ( NA to NA ) [1]
  NA  
  ( NA to NA ) [1]
[1] Median time to event and 95% confidence intervals could not be estimated due to the low number of events.


Statistical Analysis 1 for Disease-free Survival in Stage III Cancer Patients - Time to Event
Groups [1] All groups
Method [2] Closed test procedure
P Value [3] 0.2024
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Adjustments for multiplicity was done using a closed test procedure which tests for differences between all three treatment groups at the 5% alpha level first. Only in case of a significant result, the pair-wise comparison between the control arm and each of the bevacizumab arm will be tested, again at the 5% alpha level.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



2.  Primary:   Disease-free Survival in Stage III Cancer Patients - Number of Events   [ Time Frame: From first patient randomized until the data cut-off date of 30 June 2010 (36 months after the last patient randomized). ]

3.  Secondary:   Overall Survival in Stage III Cancer Patients - Time to Event   [ Time Frame: From first patient randomized until the clinical data cut-off date of 30 June 2010 (36 months after the last patient randomized). ]

4.  Secondary:   Overall Survival in Stage III Cancer Patients - Number of Events   [ Time Frame: From first patient randomized until the clinical data cut-off date of 30 June 2010 (36 months after the last patient randomized). ]

5.  Secondary:   Overall Survival in Stage III Cancer Patients - Time to Event: Final Analysis   [ Time Frame: From first patient randomized until the final data cut-off date of 30 June 2012 (5 years after the last patient randomized). ]

6.  Secondary:   Overall Survival in Stage III Cancer Patients - Number of Events: Final Analysis   [ Time Frame: From first patient randomized until the final data cut-off date of 30 June 2012 (5 years after the last patient randomized). ]


  Serious Adverse Events


  Other Adverse Events
  Hide Other Adverse Events

Time Frame All adverse events occurring between the date of first drug intake and 28 days after last drug intake, regardless of which treatment group the patient was randomized to.
Additional Description No text entered.

Frequency Threshold
Threshold above which other adverse events are reported   5%  

Reporting Groups
  Description
FOLFOX4

Weeks 1-24: Oxaliplatin was administered as an 85 mg/m^2 intravenous infusion over 2 hours concomitantly with Leucovorin as a 200 mg/m^2 infusion over 2 hours, followed by 5-FU, given as a 400 mg/m^2 bolus injection, and then as a 600 mg/m^2 continuous infusion over 22 hours. Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection, and 5-FU 600 mg/m^2 continuous infusion were repeated on day 2. Cycle length was 2 weeks and cycles were repeated every second week for a total of 12 cycles (24 weeks).

Weeks 25-48: Observation only.

FOLFOX4 + Bv

Weeks 1–24: Bevacizumab 5 mg/kg was administered as an intravenous infusion over 30 – 90 minutes followed by oxaliplatin, administered as an 85 mg/m^2 intravenous infusion over 2 hours (on day 1 only) concomitantly with leucovorin, as a 200 mg/m^2 infusion over 2 hours, followed by 5-FU, given as a 400 mg/m^2 bolus injection, and then as a 600 mg/m^2 continuous infusion over 22 hours. Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection, and 5-FU 600 mg/m^2 continuous infusion are repeated on day 2. Cycle length is 2 weeks and cycles were repeated every second week for a total of 12 cycles (24 weeks).

Weeks 25–48: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 minutes. Cycle length was 3 weeks. Cycles were repeated every 3 weeks for a total of 8 cycles (24 weeks).

XELOX+Bv

Weeks 1–24: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 – 90 minutes followed by oxaliplatin administered as a 130 mg/m^2 intravenous infusion over 2 hours (day 1 every 3 weeks) in combination with capecitabine, which was administered orally at a dose of 1000 mg/m^2 twice daily (equivalent to a total daily dose of 2000 mg/m^2), with first dose the evening of day 1 and last dose the morning of day 15, given as intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment), for a total of 8 cycles (24 weeks).

Weeks 25–48: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 minutes. Cycle length was 3 weeks. Cycles were repeated every 3 weeks for a total of 8 cycles (24 weeks).


Other Adverse Events
    FOLFOX4     FOLFOX4 + Bv     XELOX+Bv  
Total, other (not including serious) adverse events        
# participants affected / at risk     1112/1126     1127/1145     1117/1135  
Blood and lymphatic system disorders        
Neutropenia † 1      
# participants affected / at risk     660/1126 (58.61%)     567/1145 (49.52%)     273/1135 (24.05%)  
Thrombocytopenia † 1      
# participants affected / at risk     331/1126 (29.40%)     115/1145 (10.04%)     99/1135 (8.72%)  
Anaemia † 1      
# participants affected / at risk     116/1126 (10.30%)     89/1145 (7.77%)     74/1135 (6.52%)  
Leukopenia † 1      
# participants affected / at risk     79/1126 (7.02%)     55/1145 (4.80%)     34/1135 (3.00%)  
Eye disorders        
Lacrimation increased † 1      
# participants affected / at risk     70/1126 (6.22%)     69/1145 (6.03%)     35/1135 (3.08%)  
Gastrointestinal disorders        
Nausea † 1      
# participants affected / at risk     725/1126 (64.39%)     761/1145 (66.46%)     720/1135 (63.44%)  
Diarrhoea † 1      
# participants affected / at risk     620/1126 (55.06%)     699/1145 (61.05%)     699/1135 (61.59%)  
Vomiting † 1      
# participants affected / at risk     385/1126 (34.19%)     394/1145 (34.41%)     460/1135 (40.53%)  
Stomatitis † 1      
# participants affected / at risk     310/1126 (27.53%)     360/1145 (31.44%)     246/1135 (21.67%)  
Constipation † 1      
# participants affected / at risk     308/1126 (27.35%)     324/1145 (28.30%)     219/1135 (19.30%)  
Abdominal pain † 1      
# participants affected / at risk     220/1126 (19.54%)     227/1145 (19.83%)     214/1135 (18.85%)  
Dyspepsia † 1      
# participants affected / at risk     126/1126 (11.19%)     162/1145 (14.15%)     84/1135 (7.40%)  
Abdominal pain upper † 1      
# participants affected / at risk     86/1126 (7.64%)     118/1145 (10.31%)     113/1135 (9.96%)  
Haemorrhoids † 1      
# participants affected / at risk     29/1126 (2.58%)     68/1145 (5.94%)     41/1135 (3.61%)  
General disorders        
Fatigue † 1      
# participants affected / at risk     404/1126 (35.88%)     425/1145 (37.12%)     355/1135 (31.28%)  
Asthenia † 1      
# participants affected / at risk     241/1126 (21.40%)     251/1145 (21.92%)     250/1135 (22.03%)  
Pyrexia † 1      
# participants affected / at risk     186/1126 (16.52%)     185/1145 (16.16%)     106/1135 (9.34%)  
Mucosal inflammation † 1      
# participants affected / at risk     85/1126 (7.55%)     85/1145 (7.42%)     57/1135 (5.02%)  
Temperature intolerance † 1      
# participants affected / at risk     61/1126 (5.42%)     61/1145 (5.33%)     50/1135 (4.41%)  
Oedema peripheral † 1      
# participants affected / at risk     54/1126 (4.80%)     62/1145 (5.41%)     45/1135 (3.96%)  
Immune system disorders        
Drug hypersensitivity † 1      
# participants affected / at risk     66/1126 (5.86%)     72/1145 (6.29%)     32/1135 (2.82%)  
Infections and infestations        
Nasopharyngitis † 1      
# participants affected / at risk     76/1126 (6.75%)     92/1145 (8.03%)     70/1135 (6.17%)  
Upper respiratory tract infection † 1      
# participants affected / at risk     52/1126 (4.62%)     87/1145 (7.60%)     55/1135 (4.85%)  
Investigations        
Weight increased † 1      
# participants affected / at risk     58/1126 (5.15%)     81/1145 (7.07%)     68/1135 (5.99%)  
Weight decreased † 1      
# participants affected / at risk     26/1126 (2.31%)     56/1145 (4.89%)     61/1135 (5.37%)  
Metabolism and nutrition disorders        
Decreased appetite † 1      
# participants affected / at risk     268/1126 (23.80%)     324/1145 (28.30%)     295/1135 (25.99%)  
Musculoskeletal and connective tissue disorders        
Arthralgia † 1      
# participants affected / at risk     63/1126 (5.60%)     140/1145 (12.23%)     122/1135 (10.75%)  
Pain in extremity † 1      
# participants affected / at risk     63/1126 (5.60%)     78/1145 (6.81%)     116/1135 (10.22%)  
Back pain † 1      
# participants affected / at risk     79/1126 (7.02%)     87/1145 (7.60%)     66/1135 (5.81%)  
Musculoskeletal pain † 1      
# participants affected / at risk     35/1126 (3.11%)     86/1145 (7.51%)     46/1135 (4.05%)  
Myalgia † 1      
# participants affected / at risk     39/1126 (3.46%)     70/1145 (6.11%)     56/1135 (4.93%)  
Nervous system disorders        
Peripheral sensory neuropathy † 1      
# participants affected / at risk     430/1126 (38.19%)     430/1145 (37.55%)     436/1135 (38.41%)  
Paraesthesia † 1      
# participants affected / at risk     310/1126 (27.53%)     328/1145 (28.65%)     314/1135 (27.67%)  
Neuropathy peripheral † 1      
# participants affected / at risk     252/1126 (22.38%)     234/1145 (20.44%)     204/1135 (17.97%)  
Headache † 1      
# participants affected / at risk     169/1126 (15.01%)     284/1145 (24.80%)     219/1135 (19.30%)  
Dysgeusia † 1      
# participants affected / at risk     237/1126 (21.05%)     222/1145 (19.39%)     152/1135 (13.39%)  
Dysaesthesia † 1      
# participants affected / at risk     128/1126 (11.37%)     106/1145 (9.26%)     128/1135 (11.28%)  
Dizziness † 1      
# participants affected / at risk     102/1126 (9.06%)     117/1145 (10.22%)     79/1135 (6.96%)  
Neurotoxicity † 1      
# participants affected / at risk     60/1126 (5.33%)     69/1145 (6.03%)     50/1135 (4.41%)  
Lethargy † 1      
# participants affected / at risk     44/1126 (3.91%)     50/1145 (4.37%)     59/1135 (5.20%)  
Psychiatric disorders        
Insomnia † 1      
# participants affected / at risk     135/1126 (11.99%)     132/1145 (11.53%)     91/1135 (8.02%)  
Anxiety † 1      
# participants affected / at risk     45/1126 (4.00%)     60/1145 (5.24%)     61/1135 (5.37%)  
Renal and urinary disorders        
Proteinuria † 1      
# participants affected / at risk     19/1126 (1.69%)     73/1145 (6.38%)     69/1135 (6.08%)  
Respiratory, thoracic and mediastinal disorders        
Epistaxis † 1      
# participants affected / at risk     228/1126 (20.25%)     424/1145 (37.03%)     216/1135 (19.03%)  
Cough † 1      
# participants affected / at risk     86/1126 (7.64%)     120/1145 (10.48%)     41/1135 (3.61%)  
Dyspnoea † 1      
# participants affected / at risk     57/1126 (5.06%)     74/1145 (6.46%)     73/1135 (6.43%)  
Dysphonia † 1      
# participants affected / at risk     17/1126 (1.51%)     91/1145 (7.95%)     74/1135 (6.52%)  
Dysaesthesia pharynx † 1      
# participants affected / at risk     37/1126 (3.29%)     28/1145 (2.45%)     79/1135 (6.96%)  
Oropharyngeal pain † 1      
# participants affected / at risk     52/1126 (4.62%)     59/1145 (5.15%)     33/1135 (2.91%)  
Skin and subcutaneous tissue disorders        
Palmar-Plantar Erythrodysaesthesia Syndrome † 1      
# participants affected / at risk     98/1126 (8.70%)     119/1145 (10.39%)     435/1135 (38.33%)  
Alopecia † 1      
# participants affected / at risk     231/1126 (20.52%)     241/1145 (21.05%)     73/1135 (6.43%)  
Rash † 1      
# participants affected / at risk     114/1126 (10.12%)     112/1145 (9.78%)     110/1135 (9.69%)  
Dry skin † 1      
# participants affected / at risk     52/1126 (4.62%)     66/1145 (5.76%)     50/1135 (4.41%)  
Pruritus † 1      
# participants affected / at risk     36/1126 (3.20%)     65/1145 (5.68%)     28/1135 (2.47%)  
Vascular disorders        
Hypertension † 1      
# participants affected / at risk     196/1126 (17.41%)     472/1145 (41.22%)     468/1135 (41.23%)  
Events were collected by systematic assessment
1 Term from vocabulary, MedDRA (13.0)



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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 agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Medical Communications
Organization: Hoffman-LaRoche
phone: 800-821-8590


No publications provided by Hoffmann-La Roche

Publications automatically indexed to this study:

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00112918     History of Changes
Other Study ID Numbers: CDR0000427299, P30CA016042, UCLA-0412086-01, ROCHE-BO17920A
Study First Received: June 2, 2005
Results First Received: June 1, 2012
Last Updated: June 19, 2013
Health Authority: United States: Food and Drug Administration