Frequencies of toxicity included in analyses by treatment phase
| Treatment phase . | Toxicity . | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Gastrointestinal . | Infection . | Hyperbilirubinemia . | Peripheral neuropathy . | Central nervous system . | |||||||||
| Grade 3 . | Grade 4 . | Grade 3 . | Grade 4 . | Grade 2 . | Grade 3 . | Grade 4 . | Grade 2 . | Grade 3 . | Grade 4 . | Grade 2 . | Grade 3 . | Grade 4 . | |
| Induction, total no. of patients* with toxicity | 14 | 2 | 28 | 7 | 49 | 17 | 6 | — | 8 | 0 | 0† | 2† | 0† |
| Consolidation, total no. of patients* with toxicity | 16 | 3 | 7 | 0 | 21 | 5 | 0 | 3† | 1† | 0† | 0† | 2† | 0† |
| Continuation, total no. of episodes (no. of patients*) | 61 (41) | 9 (7) | 97 (62) | 21 (18) | — | 59 (34) | 12 (9) | — | 43 (29) | 1 (1) | — | 7 (6) | 23 (13) |
| Continuation, total no. of episodes of toxicity/wk at risk | 0.002866 | 0.000423 | 0.004558 | 0.000987 | — | 0.00277 | 0.0005 | 0.004981 | 0.0020 | 0.00004 | 0.00004 | 0.0003 | 0.00108 |
| Continuation, total no. of patients with toxicity/wk at risk | 0.001926 | 0.000329 | 0.002913 | 0.000846 | — | 0.00159 | 0.0004 | 0.002772 | 0.0013 | 0.00004 | 0.00004 | 0.0002 | 0.00108 |
| Treatment phase . | Toxicity . | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Gastrointestinal . | Infection . | Hyperbilirubinemia . | Peripheral neuropathy . | Central nervous system . | |||||||||
| Grade 3 . | Grade 4 . | Grade 3 . | Grade 4 . | Grade 2 . | Grade 3 . | Grade 4 . | Grade 2 . | Grade 3 . | Grade 4 . | Grade 2 . | Grade 3 . | Grade 4 . | |
| Induction, total no. of patients* with toxicity | 14 | 2 | 28 | 7 | 49 | 17 | 6 | — | 8 | 0 | 0† | 2† | 0† |
| Consolidation, total no. of patients* with toxicity | 16 | 3 | 7 | 0 | 21 | 5 | 0 | 3† | 1† | 0† | 0† | 2† | 0† |
| Continuation, total no. of episodes (no. of patients*) | 61 (41) | 9 (7) | 97 (62) | 21 (18) | — | 59 (34) | 12 (9) | — | 43 (29) | 1 (1) | — | 7 (6) | 23 (13) |
| Continuation, total no. of episodes of toxicity/wk at risk | 0.002866 | 0.000423 | 0.004558 | 0.000987 | — | 0.00277 | 0.0005 | 0.004981 | 0.0020 | 0.00004 | 0.00004 | 0.0003 | 0.00108 |
| Continuation, total no. of patients with toxicity/wk at risk | 0.001926 | 0.000329 | 0.002913 | 0.000846 | — | 0.00159 | 0.0004 | 0.002772 | 0.0013 | 0.00004 | 0.00004 | 0.0002 | 0.00108 |
— indicates that this grade of event was not considered toxic for this phase.
The number of patients or episodes of toxicity were analyzed, broken down by NCI grade and phase; for example, for hyperbilirubinemia during induction or consolidation, grades 2, 3, and 4 episodes were considered as toxic, whereas for continuation, only grades 3 and 4 episodes were considered as toxic for purposes of the analyses. The total numbers of the patients at risk were 240, 239, and 237 during the induction, consolidation, and continuation phases, respectively.
Not analyzed statistically because of too few events.