Randomization
. | Risk group, no. . | . | . | . | . | ||||
|---|---|---|---|---|---|---|---|---|---|
. | R1 . | R2 . | R3 . | R4 . | Total . | ||||
| No. of patients | 48 | 233 | 82 | 142 | 505 | ||||
| Early death before randomization | 0 | 0 | 0 | 1 | 1 | ||||
| No. patients randomized in arm MTX-4h | 21 | 93 | 26 | 40 | 180 | ||||
| Refused, MTX-24h given | 1 | 5 | 1 | 3 | 10 | ||||
| No. patients randomized in arm MTX-24h | 19 | 96 | 31 | 38 | 184 | ||||
| Refused, MTX-4h given | 0 | 1 | 0 | 0 | 1 | ||||
| Not randomized* | |||||||||
| MTX-4h chosen | 2 | 7 | 1 | 3 | 13 | ||||
| MTX-24h chosen | 3 | 33 | 4 | 10 | 50 | ||||
| Randomization halted† | 3 | 4 | 3 | 10 | 20 | ||||
| Randomization stopped in R3 + R4 | |||||||||
| MTX-24h given‡ | NA | NA | 17 | 40 | 57 | ||||
. | Risk group, no. . | . | . | . | . | ||||
|---|---|---|---|---|---|---|---|---|---|
. | R1 . | R2 . | R3 . | R4 . | Total . | ||||
| No. of patients | 48 | 233 | 82 | 142 | 505 | ||||
| Early death before randomization | 0 | 0 | 0 | 1 | 1 | ||||
| No. patients randomized in arm MTX-4h | 21 | 93 | 26 | 40 | 180 | ||||
| Refused, MTX-24h given | 1 | 5 | 1 | 3 | 10 | ||||
| No. patients randomized in arm MTX-24h | 19 | 96 | 31 | 38 | 184 | ||||
| Refused, MTX-4h given | 0 | 1 | 0 | 0 | 1 | ||||
| Not randomized* | |||||||||
| MTX-4h chosen | 2 | 7 | 1 | 3 | 13 | ||||
| MTX-24h chosen | 3 | 33 | 4 | 10 | 50 | ||||
| Randomization halted† | 3 | 4 | 3 | 10 | 20 | ||||
| Randomization stopped in R3 + R4 | |||||||||
| MTX-24h given‡ | NA | NA | 17 | 40 | 57 | ||||
NA indicates not applicable.
Not randomized due to patients/guardians refusal or by physicians in charge.
Because there was a trend for inferior results in the randomized arm MTX-4h, after the first and second interim analysis randomization was halted in blinded fashion for the time period until approval and recommendation of the external data safety and monitoring committee and the study committee regarding continuation or stopping of the trial. During this period, all requests for randomization of patients were answered with the allocation MTX-24 h.
In risk groups R3 and R4, randomization was stopped after the second interim analysis.