Table 7.
Analysis of adverse events in patients <12 years according to age, weight, graft source, GvHD characteristics, dose and lines of previous therapies.
| Patients (N) | Adverse events | No adverse events | Uni-variate analysis | Multi-variate stepwise analysis | ||
|---|---|---|---|---|---|---|
| Odds Ratio for adverse events (IC 95%) | P | Odds Ratio for adverse events (IC 95%) | P | |||
| Age | ||||||
| >6 years (42) | 21 (50) | 21 (50) | Ref | |||
| <6 years (38) | 17 (45) | 21 (55) | 1.23 (0.51–3.00) | 0.60 | 1.03 (0.77–1.38) | 0.82 |
| Weight | ||||||
| >25 Kg (18) | 11 (61) | 7 (39) | Ref | 0.20 | 2.7 (0.38–19.26) | 0.32 |
| <25 Kg (50) | 22 (44) | 28 (56) | 2.00 (0.68–6.25) | |||
| Type of GvHD | ||||||
| Acute GvHD (26) | 19 (73) | 7 (27) | Ref | 0.02 | 5.22 (1.03–26.5) | 0.046 |
| Chronic GvHD (24) | 10 (42) | 14 (58) | 3.8 (1.19–13.09) | |||
| Source of HSC | Excluded by stepwise selection | - | ||||
| BM (30) | 20 (67) | 10 (33) | Ref | |||
| PB (18) | 8 (44) | 55 (56) | 1.8 (0.66–5.51) | 0.24 | ||
| CB (2) | 1 (50) | 1 (50) | ||||
| Previous lines of therapy | ||||||
| 1–2 (14) | 20 (56) | 16 (44) | Ref | 0.57 | 0.75 (0.45–1.26) | 0.28 |
| >2 (36) | 9 (64) | 5 (36) | 0.69 (0.18–2.43) | |||
| Daily dose | ||||||
| >10 mg daily (11) | 6 (55) | 5 (45) | Ref | 0.79 | 0.43 (0.09–28.9) | 0.75 |
| <10 mg daily (39) | 23 (58) | 16 (42) | 0.83 (0.21–3.34) | |||
| Starting dose | Excluded by stepwise selection | - | ||||
| >10 mg daily (18) | 10 (56) | 8 (44) | Ref 0.86 (0.26–2.79) | 0.79 | ||
| <10 mg daily (32) | 19 (59) | 13 (41) | ||||
Bold values indicate statistically significant results in the multi-variate stepwise analysis.