Table 4.
GRA at week 12 in the KRP‐116D and placebo groups
|
KRP‐116D n = 49 |
Placebo n = 47 |
|
|---|---|---|
| Frequency of GRA (post‐dose), n (%) | ||
| 1: Markedly improved | 12 (25.0) | 5 (10.9) |
| 2: Moderately improved | 13 (27.1) | 9 (19.6) |
| 3: Slightly improved | 15 (31.3) | 21 (45.7) |
| 4: No change | 4 (8.3) | 11 (23.9) |
| 5: Slightly worse | 2 (4.2) | 0 (0.0) |
| 6: Moderately worse | 2 (4.2) | 0 (0.0) |
| 7: Markedly worse | 0 (0.0) | 0 (0.0) |
| Responder (1 + 2) | 25 (52.1) | 14 (30.4) |
| Non‐responder (3 + 4 + 5 + 6 +7) | 23 (47.9) | 32 (69.6) |
| Difference between the groups | ||
| Difference (%) | 21.6 | |
| 95% CI | (1.8, 39.2) | |
| P‐value (Fisher's exact test) | 0.0385 | |
Analysis set: full analysis set.