Bleeding/spotting outcomes by 90-day reference period (full analysis set)
| FlexibleMIB | Conventional | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| 90-day phase | n | Mean (SD) | Median | Range | Q1, Q3 | n | Mean (SD) | Median | Range | Q1, Q3 | |
| Number of days with bleeding/ spotting | 1 | 111 | 19.9 (13.0) | 17 | 1–66 | 10.0, 30.0 | 101 | 25.3 (9.1) | 23 | 4–49 | 18.0, 30.0 |
| 2 | 90 | 12.9 (8.3) | 12 | 0–38 | 7.0, 16.0 | 47 | 15.7 (5.9) | 15 | 0–37 | 13.0, 18.0 | |
| Number of bleeding/spotting episodes | 1 | 93 | 2.4 (1.7) | 2 | 0–10 | 1.0, 3.0 | 101 | 3.5 (1.0) | 3 | 1–8 | 3.0, 4.0 |
| 2 | 90 | 2.7 (1.7) | 3 | 0–10 | 2.0, 3.0 | 47 | 3.2 (0.8) | 3 | 0–5 | 3.0, 4.0 | |
| Length of bleeding/spotting episodes | 1 | 92 | 7.8 (9.0) | 6 | 1–79 | 3.6, 9.0 | 101 | 5.2 (1.8) | 5 | 2–12 | 4.0, 6.0 |
| 2 | 85 | 5.1 (2.5) | 5 | 1–15 | 3.5, 6.0 | 46 | 5.1 (1.5) | 5 | 2–9 | 4.0, 6.3 | |
| Maximum length of bleeding/ spotting episodes | 1 | 92 | 10.2 (9.7) | 9 | 1–79 | 5.5, 11.0 | 101 | 7.5 (3.7) | 6 | 3–20 | 5.0, 8.0 |
| 2 | 85 | 6.9 (3.9) | 6 | 1–23 | 5.0, 8.0 | 46 | 6.0 (1.7) | 6 | 2–11 | 5.0, 7.0 | |
| Range of length of bleeding/ spotting episodes | 1 | 92 | 4.5 (5.4) | 3 | 0–31 | 0, 8.0 | 101 | 3.9 (3.9) | 3 | 1–19 | 1.0, 5.0 |
| 2 | 85 | 3.3 (4.0) | 2 | 0–22 | 0, 4.0 | 46 | 2.0 (1.9) | 1 | 0–7 | 1.0, 3.0 | |
NB. The first period includes the bleeding at treatment start. At least 60 days with data were required to be included in the evaluation of a 90-day period. In the conventional group regular treatment ended before Day 150, which led to the exclusion of many subjects in period 2.
MIB, management of intracyclic (breakthrough) bleeding; Q, quartile; SD, standard deviation.