Statement: DLT occurence, used as the outcome measurement in the secondary trial and Clinical Benefit Rate, used in the primary trial are not synonymous, and represent entirely different patient characteristics. 
Primary_evidence: Outcome Measurement:    Clinical Benefit Rate   Clinical benefit = complete response (CR), partial response (PR), or stable disease (SD) lasting for at least 6 months, assessed per Response Evaluation Criteria of Solid Tumor (RECIST).CR=disappearance of all target and non-target lesions. PR= disappearance of or at least 30% decrease in the sum of the longest diameters of target lesions, with non-progressive disease in non-target lesions. SD= sum of the longest diameters of target lesions decrease <30% or increase <20%, with non-progressive disease in non-target lesions. 141 eligible, treated patients were included.   Time frame: assessed every 3 cycles while on treatment, assessed every 3 months when follow up <2 years, every 6 months between 2-3 years,no specific requirements after 3 years Results 1:    Arm/Group Title: Anastrozole and ZD1839   Arm/Group Description: [Not Specified]   Overall Number of Participants Analyzed: 72   Measure Type: Number   Unit of Measure: percentage of participants  44        (33 to 57) Results 2:    Arm/Group Title: Fulvestrant and ZD1839   Arm/Group Description: [Not Specified]   Overall Number of Participants Analyzed: 69   Measure Type: Number   Unit of Measure: percentage of participants  41        (29 to 53)
Secondary_evidence: Outcome Measurement:    Recurrence-free Survival   2 years for the primary analysis + 3 additional years for secondary analysis (From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years)   Time frame: 5 years Results 1:    Arm/Group Title: Ketorolac 30 mg   Arm/Group Description: Active drug to be compared with placebo   Ketorolac 30 mg IV   Overall Number of Participants Analyzed: 96   Measure Type: Count of Participants   Unit of Measure: Participants  80  83.3% Results 2:    Arm/Group Title: NaCl 0.9% 3mL   Arm/Group Description: Ketorolac 30 mg IV   Overall Number of Participants Analyzed: 107   Measure Type: Count of Participants   Unit of Measure: Participants  96  89.7%