Table 4.
Known groups validity analysis with MP and reference measures (monthly sum scores)
| 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) | |||
“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, 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
aJonckheere-Terpstra test
bKruskal-Wallis test
cAs the first and the second tertile are the same at EOT, only two groups based on tertiles were defined