Table 2.
Adverse neurologic events.
| No. of patients affected (%) | No. of Events ( occurrence rate per IT treatment) | Treatment | RR | 95% CI | P Value | |
|---|---|---|---|---|---|---|
| Significant Neuro Events | 9 (8.26) | 11 (3.10) | ||||
|
| ||||||
| Overall∗ | MTX | 1 | - | - | ||
| CYT | 1.67 | 0.19-14.27 | 0.641 | |||
| MTX and CYT | 1.16 | 0.50-2.71 | 0.728 | |||
|
| ||||||
| Paresthesias | 8 (7.34) | 10 (2.82) | ||||
|
| ||||||
| MTX | 1 | - | - | |||
| CYT | 1.67 | 0.19-14.27 | 0.64 | |||
| MTX and CYT | 0.64 | 0.17-2.39 | 0.51 | |||
|
| ||||||
| Paralysis∗∗ | 2 (1.83) | 3 (0.85) | ||||
|
| ||||||
| MTX | 1 | - | - | |||
| CYT | 8.33 | 0.52-133.23 | 0.134 | |||
| MTX and CYT | 0.80 | 0.05-12.82 | 0.876 | |||
|
| ||||||
| Minor Events | 29 (26.61) | 109 (30.70) | ||||
|
| ||||||
| Overall∗ | MTX | 1 | - | - | ||
| CYT | 1.53 | 0.75-3.12 | 0.241 | |||
| MTX and CYT | 0.97 | 0.66-1.41 | 0.857 | |||
|
| ||||||
| Asthenia | 4 (3.67) | 10 (2.82) | ||||
|
| ||||||
| MTX | 1 | - | - | |||
| CYT | 2.78 | 0.56-13.76 | 0.21 | |||
| MTX and CYT | 0.80 | 0.26-2.49 | 0.703 | |||
|
| ||||||
| Headache | 15 (13.76) | 50 (14.08) | ||||
|
| ||||||
| MTX | 1 | - | - | |||
| CYT | 1.23 | 0.43-3.53 | 0.694 | |||
| MTX and CYT | 0.68 | 0.39-1.19 | 0.180 | |||
|
| ||||||
| Back pain | 9 (8.26) | 18 (5.07) | ||||
|
| ||||||
| MTX | 1 | - | - | |||
| CYT | 2.08 | 0.44-9.81 | 0.353 | |||
| MTX and CYT | 1.00 | 0.40-2.54 | 0.996 | |||
|
| ||||||
| Fever | 5 (4.59) | 19 (5.35) | ||||
|
| ||||||
| MTX | 1 | - | - | |||
| CYT | 2.78 | 0.56-13.78 | 0.211 | |||
| MTX and CYT | 1.47 | 0.54-3.98 | 0.447 | |||
|
| ||||||
| Nausea | 13 (11.93) | 48 (13.52) | ||||
|
| ||||||
| MTX | 1 | - | - | |||
| CYT | 0.93 | 0.21-3.99 | 0.918 | |||
| MTX and CYT | 1.25 | 0.69-2.26 | 0.464 | |||
|
| ||||||
| Vomiting | 6 (5.50) | 32 (9.01) | ||||
|
| ||||||
| MTX | 1 | - | - | |||
| CYT | 1.11 | 0.25-4.86 | 0.889 | |||
| MTX and CYT | 0.91 | 0.45-1.82 | 0.788 | |||
∗Multiple major or minor events simultaneously are counted only once in overall (overall numbers are therefore less than total of subcategories).
∗∗One patient had both paresthesias and paralysis in two events. To avoid double-counting, these events were included only in paresthesias for the RR calculation.