ISSN 0377-9556 (PRINT)
ISSN 2383-9457 (ONLINE)
ISSN 2383-9457 (ONLINE)
| PRO measures (N=199) | PRO measures included in the label (N=111) | PRO measures excluded from the label (N=88) | p value | ||
|---|---|---|---|---|---|
| Endpoint status, n (%) | <0.001 | ||||
| Primary Endpoint | 73 (36.7) | 72 (64.9) | 1 (1.1) | ||
| Key Secondary Endpoint | 52 (26.1) | 30 (27.0) | 22 (25.0) | ||
| Secondary or exploratory Endpoint | 74 (37.2) | 9 ( | 8.1) | 65 (73.9) | |
| Type of measures, n (%) | <0.001 | ||||
| Disease-specific | 131 (65.8) | 89 (80.2) | 42 (47.7) | ||
| Generic | 35 (17.6) | 13 (11.7) | 22 (25.0) | ||
| Symptom-specific | 33 (16.6) | 9 (8.1) | 24 (27.3) | ||
| Measured concepts, n (%) | |||||
| Symptom | 96 (48.2) | 72 (64.9) | 26 (29.5) | <0.001 | |
| HRQoL | 57 (28.6) | 19 (17.1) | 38 (43.2) | <0.001 | |
| Function | 51 (25.6) | 30 (27.0) | 21 (23.9) | 0.794 | |
| Others | 71 (35.7) | 40 (36.0) | 31 (35.2) | 1.000 | |
| Development status, n (%) | 0.261 | ||||
| Newly developed | 16 (8.0) | 9 ( | 8.1) | 7 (8.0) | |
| Modified | 24 (17.1) | 12 (10.8) | 12 (13.6) | ||
| Established | 158 (79.4) | 90 (81.1) | 68 (77.3) | ||
| Not identified | 1 (0.5) | 0 (0.0) | 1 (1.1) |
HRQoL, Health-related quality of life
Others: Adverse events, concomitant medications. patient satisfaction, subjective health status, utility, frequency of clinical status