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Table 4 Known-groups analysis of ISM-SAF scores based on concurrent assessments administered at C4D1

From: Psychometric evaluation of the Indolent Systemic Mastocytosis Symptom Assessment Form (ISM-SAF) in a phase 2 clinical study

ISM-SAF domain Known group N Mean (SD) Median p value*
PGIS
Gastrointestinal Symptom Score (0–30) Absent/Minimal 12 4.3 (3.3) 4.2 0.009
Moderate 11 9.5 (2.9) 9.4
Severe/Very Severe 11 9.7 (6.5) 9.4
Skin Symptom Score (0–30) Absent/Minimal 12 8.1 (4.0) 8.5 < 0.001
Moderate 11 12.6 (6.0) 10.9
Severe/Very Severe 11 18.3 (6.5) 20.4
Total Symptom Score (0–110) Absent/Minimal 12 27.1 (10.2) 26.8 < 0.001
Moderate 11 50.4 (12.1) 50.9
Severe/Very Severe 11 55.2 (15.1) 55.9
EQ-5D-5L VAS
Gastrointestinal Symptom Score (0–30) Severe (1st tertile) 11 11.0 (5.6) 10.6 0.028
Moderate (2nd tertile) 12 6.5 (5.0) 6.2
Mild (3rd tertile) 11 5.8 (2.9) 5.1
Skin Symptom Score (0–30) Severe (1st tertile) 11 16.2 (5.9) 19.0 0.144
Moderate (2nd tertile) 12 11.8 (7.9) 9.4
Mild (3rd tertile) 11 10.8 (5.9) 9.9
Total Symptom Score (0–110) Severe (1st tertile) 11 55.5 (15.7) 55.9 0.003
Moderate (2nd tertile) 12 44.0 (16.1) 44.1
Mild (3rd tertile) 11 31.5 (13.0) 28.1
MC-QoL Symptom
Gastrointestinal Symptom Score (0–30) Mild (1st tertile) 10 4.7 (3.6) 4.2 0.014
Moderate (2nd tertile) 12 7.3 (3.7) 7.6
Severe (3rd tertile) 12 10.7 (5.8) 11.1
Skin Symptom Score (0–30) Mild (1st tertile) 10 9.7 (7.1) 9.0 0.104
Moderate (2nd tertile) 12 12.5 (6.3) 10.4
Severe (3rd tertile) 12 15.9 (6.5) 19.3
Total Symptom Score (0–110) Mild (1st tertile) 10 29.5 (10.6) 27.6 < 0.001
Moderate (2nd tertile) 12 43.4 (16.4) 46.3
Severe (3rd tertile) 12 55.8 (14.8) 55.7
SF-12v2® PCS
Gastrointestinal Symptom Score (0–30) Severe (1st tertile) 11 10.6 (3.2) 10.6 0.032
Moderate (2nd tertile) 12 7.6 (6.5) 5.7
Mild (3rd tertile) 11 5.0 (3.3) 4.5
Skin Symptom Score (0–30) Severe (1st tertile) 11 13.8 (7.1) 15.0 0.366
Moderate (2nd tertile) 12 14.2 (5.7) 13.0
Mild (3rd tertile) 11 10.4 (7.7) 9.6
Total Symptom Score (0–110) Severe (1st tertile) 11 53.4 (10.8) 55.6 0.002
Moderate (2nd tertile) 12 47.8 (19.6) 45.0
Mild (3rd tertile) 11 29.4 (11.4) 27.1
  1. C#D# cycle number, day number, EQ-5D-5L Five-level EQ-5D, ISM-SAF Indolent Systemic Mastocytosis Symptom Assessment Form, MC-QoL Mastocytosis Quality of Life Questionnaire, PCS Physical Component Summary, PGIS Patient Global Impression of Severity, SD standard deviation, VAS visual analogue scale
  2. *p values from are from one-way analysis of variance (ANOVA) testing of mean score differences between groups