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