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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.