Table 3.
PBAC bleeding diary scores in the primary population A.
| UPA N (%) |
LNG-IUS N (%) |
Odds ratioa (95%CI) | |
|---|---|---|---|
| Baseline | |||
| Amenorrhoea (=0) | 0 (−) | 0 (−) | |
| Light (1–10) | 0 (−) | 0 (−) | |
| Normal (>10–100) | 4 (5%) | 11 (15%) | |
| Heavy (>100) | 75 (95%) | 61 (85%) | |
| Median score [IQR] | 306 [173–534] | 204 [138–455] | |
| TOTAL | N = 79 | N = 72 | |
| 3 Months | |||
| Amenorrhoea (=0) | 31 (56%) | 3 (5%) | 29.3 (7.37, 116) |
| Light (1–10) | 6 (11%) | 8 (13%) | |
| Normal (>10–100) | 4 (7%) | 32 (50%) | |
| Heavy (>100) | 14 (25%) | 21 (33%) | 0.64 (0.27, 1.53) |
| Median score [IQR] | 0 [0–199] | 53 [21–170] | |
| TOTAL | N = 55 | N = 64 | |
| 6 Months | |||
| Amenorrhoea (=0) | 20 (53%) | 5 (10%) | 11.7 (3.78, 36.0) |
| Light (1–10) | 3 (8%) | 10 (20%) | |
| Normal (>10–100) | 10 (26%) | 29 (57%) | |
| Heavy (>100) | 5 (13%) | 7 (14%) | 0.83 (0.23, 2.9) |
| Median score [IQR] | 0 [0–37] | 22 [7–70] | |
| TOTAL | N = 38 | N = 51 | |
| 12 Months | |||
| Amenorrhoea (=0) | 18 (64%) | 10 (25%) | 7.12 (2.29, 22.2) |
| Light (1–10) | 0 (−) | 6 (15%) | |
| Normal (>10–100) | 5 (18%) | 12 (30%) | |
| Heavy (>100) | 5 (18%) | 12 (30%) | 0.47 (0.12, 1.79) |
| Median score [IQR] | 0 [0–58] | 28 [1–118] | |
| TOTAL | N = 28 | N = 40 |
Baseline data included for those in this analysis population and returned a form at either 3, 6 or 12 months.
a
Odds Ratio for amenorrhoea (estimates>1 favour UPA) and heavy bleeding (estimates<1 favour UPA) shown; centre removed from model due to lack of convergence; number of participants who declined to complete the Menstrual Blood Loss Diary on the grounds they are no longer having periods, therefore score assumed to be equal to 0: 3 Month (UPA = 13; LNG-IUS = 2); 6 Month (UPA = 12; LNG-IUS = 4); 12 Month (UPA = 9; LNG-IUS = 8).