Table 2. Adverse outcomes by treatment arm in eligible randomized patients.
Outcome variable | Arm 1 | Arm 2 |
---|---|---|
Tamoxifen alone N=149 | Tamoxifen+MPA N=147 | |
Breast cancer progression or death | 23 (15%) | 14 (10%) |
Removal from protocol owing to toxicity or worsening illness | 16 (11%) | 20 (14%) |
Positive EMB | 5 (3%) | 3 (2%) |
Total (any event) | 40 (27%) | 35 (24%) |
Total (Positive EMB, progression, or death) | 27 (18%) | 17 (12%) |
Abbreviations: EMB, endometrial biopsy; MPA, medroxyprogesterone acetate.
Patients may have experienced more than one adverse outcome.