Table III.
1-Year Analysis | 2-Year Analysis | |||
---|---|---|---|---|
| ||||
Onset Within 6 Months | Onset 6 to ≤12 Months | Onset Within 12 Months | Onset 12 to ≤24 Months | |
| ||||
No. of patients analyzed* | N = 72 | N = 69 | ||
No. of patients with event during the interval | 67 | 38 | 68 | 35 |
Mean (SD) No. of events per patient | 3.5 (2.6) | 2.3 (2.4) | 4.4 (3.6) | 2.7 (3.0) |
Median (IQR†) No. of events per patient | 3.0 (1.0, 5.0) | 1.5 (1.0, 3.0) | 3.0 (2.0, 6.0) | 2.0 (1.0, 3.0) |
P value‡ | < .001 | < .001 |
To be included in the 1-year analysis, patients must have been alive and on follow-up for at least 365 days after administration of cultured thymus tissue, and experienced at least one infection-related AE during one or both onset periods.
To be included in the 2-year analysis, patients must have been alive and on follow-up for at least 790 days after administration of cultured thymus tissue, and experienced at least one infection-related AE during one or both onset periods.
Number of patients who had events during the analysis period.
IQR, interquartile range.
2-sided P value based on a Wilcoxon signed-rank test of the mean difference in the number of infection-related AEs per patient between the first and second intervals.