Skip to main content

Table 4 Known groups validity analysis with MP 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 MP SAP-c v3 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 85.84 (102.89) 7374.0 / <.0001 46.5 / <.0001
Group 2
(2 ≤ AH monthly sum score < 80 mL)
42 137.46 (142.08)
Group 3
(AH monthly sum score ≥ 80 mL)
161 224.92 (130.08)
EOT Group 1
(AH monthly sum score < 2 mL)
144 0.72 (6.38) 8078.0 / <.0001 167.0 / <.0001
Group 2
(2 ≤ AH monthly sum score < 80 mL)
25 73.24 (45.53)
Group 3
(AH monthly sum score ≥ 80 mL)
27 210.19 (158.00)
Known groups validity: Differences in MP monthly sum scores between groups defined by AH method (thresholds defined by AH tertiles)
RND Group 1
(AH monthly sum score Tertile 1)
72 129.19 (118.69) 12,791.0 / <.0001 98.6 / <.0001
Group 2
(AH monthly sum score Tertile 2)
72 173.04 (72.45)
Group 3
(AH monthly sum score Tertile 3)
71 299.36 (150.48)
EOT Group 1/2c
(AH monthly sum score Tertile 1 + Tertile 2)
136 0.61 (6.53) 8127.0 / <.0001 177.8 / <.0001
Group 3
(AH monthly sum score Tertile 3)
60 125.44 (135.40)
Differences in MP monthly sum scores between groups defined by PGI-S
RND Group 1
(PGI-S = 1,2 [None/Very mild])
15 159.40 (94.96) 17,216.5 / <.0001 19.2 / 0.0007
Group 2
(PGI-S = 3 [Mild])
24 169.23 (67.59)
Group 3
(PGI-S = 4 [Moderate])
92 200.22 (130.95)
Group 4
(PGI-S = 5 [Severe])
98 202.27 (136.39)
Group 5
(PGI-S = 6 [Very severe])
52 287.05 (199.23)
EOT Group 1
(PGI-S = 1,2 [None/Very mild])
98 12.80 (45.40) 15,628.0 / <.0001 30.5 / <.0001
Group 2
(PGI-S = 3 [Mild])
56 28.30 (54.07)
Group 3
(PGI-S = 4 [Moderate])
62 54.98 (97.59)
Group 4
(PGI-S = 5 [Severe])
35 116.31 (186.47)
Group 5
(PGI-S = 6 [Very severe])
9 54.13 (122.29)
  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, MP (MP SAP-c v3) Menstrual pictogram superabsorbent polymer-containing version 3, N Number of patients, PGI-S Patient Global Impression of Severity, RND Randomization, SD Standard deviation
  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 were defined