Statement: The patient with the shortest PFS was in the secondary trial and the longest recorded PFS was in the primary trial.
Primary_evidence: Outcome Measurement:    Progression Free Survival (PFS)   Defined as the time from the date of randomization to the date of the first documentation of objective tumor progression or death due to any cause, whichever occurs first. If tumor progression data include more than 1 date, the first date will be used. PFS (in months) will be calculated as (first event date minus randomization date plus 1) divided by 30.4.   Time frame: Baseline until disease progression (up to 3 years from first dose) Results 1:    Arm/Group Title: Sunitinib + Capecitabine   Arm/Group Description: Sunitinib administered orally at a starting dose of 37.5 mg once a day on a continuous regimen. Capecitabine administered orally at a starting dose of 2000 mg/m^2 per day (1000 mg/m^2 BID) from Days 1-14 every 3 weeks.   Overall Number of Participants Analyzed: 221   Median (95% Confidence Interval)   Unit of Measure: months  Independent radiology assessment: 5.5        (4.5 to 6.0)   Investigator's assessment: 5.4        (4.4 to 5.8) Results 2:    Arm/Group Title: Capecitabine   Arm/Group Description: Capecitabine administered orally at a starting dose of 2500 mg/m^2 per day (1250 mg/m^2 BID) from Days 1-14 every 3 weeks. At the time of progression, participants could have been eligible to crossover to single agent sunitinib, administered orally at a starting dose of 37.5 mg daily continuously.   Overall Number of Participants Analyzed: 221   Median (95% Confidence Interval)   Unit of Measure: months  Independent radiology assessment: 5.9        (5.4 to 7.6)   Investigator's assessment: 5.5        (4.3 to 6.8)
Secondary_evidence: Outcome Measurement:    Progression-Free Survival (PFS) Rate   PFS was based on Kaplan-Meier estimates. PFS was defined as time in weeks from start of study treatment to first documentation of objective tumor progression or death due to any cause. PFS was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 7. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from death case report forms (CRFs). Percentage of participants who had not experienced progression or death by Week 16 is reported.   Time frame: Baseline up to Week 16 Results 1:    Arm/Group Title: Bosutinib   Arm/Group Description: Four bosutinib 100 milligram (mg) capsules, equivalent to 400 mg bosutinib orally once daily for 48 weeks, or until disease progression, unacceptable toxicity or withdrawal of consent occurred.   Overall Number of Participants Analyzed: 73   Measure Type: Number   Unit of Measure: percentage of participants  39.6        (28.1 to 50.8)