Table 5.
Known groups validity analysis with UF-DBD and reference measures (monthly sum scores)
| Time period | Groups | N | Mean (SD) | Test statistic/P valuea | Test statistic/P valueb |
|---|---|---|---|---|---|
| Differences in UF-DBD monthly sum scores between groups defined by AH method (MBL severity thresholds of 2 mL and 80 mL defined by clinical rationale) | |||||
| RND |
Group 1 (AH monthly sum score < 2 mL) |
12 | 20.33 (14.37) | 6464.0 / <.0001 | 21.7 / <.0001 |
|
Group 2 (2 ≤ AH monthly sum score < 80 mL) |
42 | 27.31 (11.50) | |||
|
Group 3 (AH monthly sum score ≥ 80 mL) |
161 | 36.10 (15.95) | |||
| EOT |
Group 1 (AH monthly sum score < 2 mL) |
144 | 1.31 (3.81) | 7847.5 / <.0001 | 133.5 / <.0001 |
|
Group 2 (2 ≤ AH monthly sum score < 80 mL) |
25 | 24.24 (19.75) | |||
|
Group 3 (AH monthly sum score ≥ 80 mL) |
27 | 33.11 (17.95) | |||
| Differences in UF-DBD monthly sum scores between groups defined by AH method (thresholds defined by AH tertiles) | |||||
| RND |
Group 1 (AH monthly sum score Tertile 1) |
72 | 26.93 (13.15) | 10,791.0 / <.0001 | 37.1 / <.0001 |
|
Group 2 (AH monthly sum score Tertile 2) |
73 | 31.78 (9.85) | |||
|
Group 3 (AH monthly sum score Tertile 3) |
70 | 42.06 (19.21) | |||
| EOT |
Group 1/2c (AH monthly sum score Tertile 1 + Tertile 2) |
136 | 1.20 (3.83) | 7872.5 / <.0001 | 132.0 / <.0001 |
|
Group 3 (AH monthly sum score Tertile 3) |
60 | 25.42 (19.92) | |||
| Differences in UF-DBD monthly sum scores between groups defined by PGI-S | |||||
| RND |
Group 1 (PGI-S = 1,2 [None/Very mild]) |
15 | 28.00 (9.97) | 16,584.0 / 0.0011 | 12.0 / 0.0171 |
|
Group 2 (PGI-S = 3 [Mild]) |
24 | 30.50 (7.68) | |||
|
Group 3 (PGI-S = 4 [Moderate]) |
90 | 33.71 (13.53) | |||
|
Group 4 (PGI-S = 5 [Severe]) |
97 | 33.61 (13.84) | |||
|
Group 5 (PGI-S = 6 [Very severe]) |
54 | 42.24 (21.02) | |||
| EOT |
Group 1 (PGI-S = 1,2 [None/Very mild]) |
99 | 4.18 (9.04) | 15,835.5 / <.0001 | 28.8 / <.0001 |
|
Group 2 (PGI-S = 3 [Mild]) |
56 | 8.82 (15.19) | |||
|
Group 3 (PGI-S = 4 [Moderate]) |
62 | 10.02 (14.16) | |||
|
Group 4 (PGI-S = 5 [Severe]) |
36 | 24.22 (29.52) | |||
|
Group 5 (PGI-S = 6 [Very severe]) |
9 | 10.89 (20.51) | |||
“All patients with AH measurements from ASTEROID 1” refers to all patients enrolled with an existing date of visit and AH or PGI-S measurements
RND Tertile 1: (0.00 to 101.24), Tertile 2: (> 101.24 to 203.73), Tertile 3: (> 203.73 to 1164.18)
EOT Tertile 1 and Tertile 2: (0.00 to 0.00), Tertile 3: (> 0.00 to 747.94)
AH Alkaline hematin method, EOT End of treatment, MBL Menstrual blood loss, N Number of patients, PGI-S Patient Global Impression of Severity, RND Randomization, SD Standard deviation, UF-DBD Uterine Fibroid Daily Bleeding Diary
aJonckheere-Terpstra test
bKruskal-Wallis test
cAs the first and the second tertile are the same at EOT, only two groups based on tertiles are defined