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Table 1 Summary of study populations in the Breast International Group 1-98 trial

From: Interpreting breast international group (BIG) 1-98: a randomized, double-blind, phase III trial comparing letrozole and tamoxifen as adjuvant endocrine therapy for postmenopausal women with hormone receptor-positive, early breast cancer

Population Number of patients Comments
Intention-to-treat population 8,010 Eighteen randomly assigned patients withdrew consent to participate before starting treatment.
   Two-arm randomization option 1,828  
   Four-arm randomization option 6,182  
Primary core analysis population 8,010 Follow-up for two sequential treatment groups is censored at 2 years (time of treatment switch).
Monotherapy population 4,922 Patients who were randomly assigned to receive 5 years of tamoxifen alone or letrozole alone.
   Two-arm randomization option 1,828  
   Four-arm randomization option 3,094  
Sequential treatment analysis population 6,182 Patients in the intention-to-treat population enrolled in the four-arm randomization option.