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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
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