Table 1.
Age, BMI, severe skin rashes, number of women discontinuing, and months to study exit, in relation to dose of topical endoxifen.
| Characteristic | Dose group | |||
|---|---|---|---|---|
| Doses combined | 0 mg | 10 mg | 20 mg | |
| No. of women randomized | 90 | 30 | 30 | 30 |
| Assessment at baseline | ||||
| Age, mean (SDa) | 56.5 (7.5) | 54.9 (6.0) | 56.9 (8.0) | 57.7 (8.4) |
| BMIb, mean (SDa) | 25.2 (3.1) | 24.9 (2.8) | 25.6 (3.6) | 25.2 (3.1) |
| Severe skin rashesc, % | 1.1 | 3.3 | 0.0 | 0.0 |
| Assessment at study exit | ||||
| No. of women discontinuing (%) | 65 (72) | 7 (23) | 28 (93) | 30 (100) |
| Months to study exit, mean (SDa) | 3.0 (2.1) | 4.9 (2.1) | 2.5 (1.5) | 1.6 (0.8) |
| Severe skin rashesc, % | 34.5 | 3.3 | 46.7 | 55.6 |
| Difference between study exit and baseline | ||||
| Months to study exitd, mean (95% CIe) | −3.0 (−3.4 to −2.5) | −1.1 (−1.7 to −0.5) | −3.5 (−4.0 to −2.9) | −4.5 (−4.9 to −3.8) |
| Severe skin rashesc, % (95% CIe) | 33.3 (22.8 to 43.8) | 0.0 (−13.6 to 13.6) | 46.7 (26.5 to 63.9) | 55.6 (33.5 to 72.4) |
Standard deviation.
Body mass index.
Skin rashes reported as “quite a lot” or “very much.”
Month at study exit minus the study defined 6-month follow-up time.
95% confidence interval.