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Table 5 Known groups validity analysis with UF-DBD and reference measures (monthly sum scores)

From: Validation of a menstrual pictogram and a daily bleeding diary for assessment of uterine fibroid treatment efficacy in clinical studies

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)
  1. “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
  2. RND Tertile 1: (0.00 to 101.24), Tertile 2: (> 101.24 to 203.73), Tertile 3: (> 203.73 to 1164.18)
  3. EOT Tertile 1 and Tertile 2: (0.00 to 0.00), Tertile 3: (> 0.00 to 747.94)
  4. 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
  5. aJonckheere-Terpstra test
  6. bKruskal-Wallis test
  7. cAs the first and the second tertile are the same at EOT, only two groups based on tertiles are defined