Table 3.
Time to first improvement (PSDS population)
| Overall, N = 207 | |||||
|---|---|---|---|---|---|
| INCAT total score | I‐RODS centile score | Mean grip strength (dominant hand) | MRC sum score | First improvement in any criteria | |
| Number of events (improvements), n (%) | 151 (73) | 84 (41) | 123 (59) | 117 (57) | 188 (91) |
| Number of censored observations, n (%)a | 56 (27) | 123 (59) | 84 (41) | 90 (44) | 19 (9) |
| Time to first improvement, daysb | |||||
| Median | 26 | 71 | 65 | 65 | 23 |
| 95% CI | 24, 41 | 66, 86 | 64, 66 | 64, 67 | 22, 23 |
Abbreviations: CI, confidence interval; INCAT, inflammatory neuropathy cause and treatment; I‐RODS, inflammatory Rasch‐built overall disability scale; IVIG, intravenous immunoglobulin; MRC, Medical Research Council; N, number of subjects; PSDS, pre‐randomization safety data set.
Improvement was defined as a decrease in adjusted INCAT score by ≥1 point, an increase in I‐RODS centile score by ≥4 points, an increase in mean grip strength by ≥8 kPa, and an increase in MRC sum score by ≥3 points, as compared to the Reference Visit (prior to first restabilization IVIG dose).
Subjects without improvements were censored at the date of their last visit in the IgPro10 restabilization period.
Using Kaplan‐Meier estimation. Time to first improvement (days) = date of first improvement ‐ date of first IVIG infusion.