Table 2.
Summary of protocol-required targeted toxic effects, and non-hematological toxic effects that occurred in 5% of patients or more
| Purged transplantation group* | Non-purged transplantation group* | |||||||
|---|---|---|---|---|---|---|---|---|
| Grade 1–2 | Grade 3 | Grade 4 | Grade 5 | Grade 1–2 | Grade 3 | Grade 4 | Grade 5 | |
| Induction† | ||||||||
| Targeted toxic effects‡ | ||||||||
| Hearing loss | 70/242 (29%) | 16/242 (7%) | 0 | 0 | 75/243 (31%) | 17/243 (7%) | 0 | 0 |
| Cardiac left ventricular function | 13/242 (5%) | 3/242 (1%) | 1/242 (<1%) | 0 | 14/243 (6%) | 3/243 (1%) | 2/243 (1%) | 0 |
| Stomatitis/pharyngitis | 80/242 (33%) | 50/242 (21%) | 37/242 (15%) | 0 | 81/243 (33%) | 52/243 (21%) | 41/243 (17%) | 0 |
| Serum creatinine | 18/242 (7%) | 4/242 (2%) | 0 | 1/242 (<1%) | 20/243 (8%) | 5/243 (2%) | 1/243 (<1%) | 0 |
| Non-targeted toxic effects§ | ||||||||
| Infection or febrile neutropenia: catheter related infection | 0 | 32/242 (13%) | 4/242 (2%) | 0 | 1/243 (<1%) | 28/243 (12%) | 6/243 (2%) | 0 |
| Consolidation¶ | ||||||||
| Targeted toxic effects | ||||||||
| Acute vascular leak | 6/177 (3%) | 7/177 (4%) | 4/177 (2%) | 0 | 5/191 (3%) | 5/191 (3%) | 4/191 (2%) | 0 |
| Cardiac left ventricular function | 11/177 (6%) | 1/177 (<1%) | 0 | 0 | 5/191 (3%) | 2/191 (1%) | 2/191 (1%) | 0 |
| Weight gain | 7/177 (4%) | 9/177 (5%) | 1/177 (<1%) | 0 | 9/191 (5%) | 4/191 (2%) | 12/191 (6%) | 0 |
| Stomatitis or pharyngitis | 28/177 (16%) | 94/177 (53%) | 37/177 (21%) | 0 | 30/191 (16%) | 104/191 (54%) | 40/191 (21%) | 1/191 (<1%) |
| Bilirubin | 34/177 (19%) | 16/177 (9%) | 4/177 (2%) | 0 | 35/191 (18%) | 15/191 (8%) | 6/191 (3%) | 0 |
| Hepatic enlargement | 0 | 31/177 (18%) | 0 | 0 | 0 | 28/191 (15%) | 0 | 0 |
| Stem-cell infusion complications | 19/177 (11%) | 7/177 (4%) | 1/177 (<1%) | 0 | 18/191 (9%) | 7/191 (4%) | 2/191 (1%) | 0 |
| Sinusoidal obstruction syndrome | 11/177 (6%) | 10/177 (6%) | 1/177 (<1%) | 1 (<1%) | 16/191 (8%) | 5/191 (3%) | 12/191 (6%) | 0 |
| Serum creatinine | 8/177 (5%) | 2/177 (1%) | 0 | 0 | 13/191 (7%) | 2/191 (1%) | 1/191 (<1%) | 0 |
| Non-targeted toxic effects | ||||||||
| Renal failure | 0 | 1/177 (<1%) | 1/177 (<1%) | 0 | 0 | 8/191 (4%) | 3/191 (2%) | 0 |
| Infection or febrile neutropenia: catheter-related infection | 0 | 13/177 (7%) | 0 | 0 | 0 | 15/191 (8%) | 2/191 (1%) | 0 |
| Isotretinoin‖ | ||||||||
| Targeted toxic effects | ||||||||
| Hypertension | 5/98 (5%) | 1/98 (1%) | 0 | 0 | 3/94 (3%) | 3/94 (3%) | 0 | 0 |
| Haematuria | 14/98 (14%) | 0 | 0 | 0 | 15/94 (16%) | 1/94 (1%) | 1/94 (1%) | 0 |
| Serum creatinine | 10/98 (10%) | 1/98 (1%) | 0 | 0 | 12/94 (13%) | 0 | 1/94 (1%) | 0 |
| Proteinuria | 7/98 (7%) | 1/98 (1%) | 0 | 0 | 14/94 (15%) | 1/94 (1%) | 1/94 (1%) | 0 |
A given patient is counted once for a given toxicity at the highest grade within a treatment period.
One patient in the purged transplantation group died on day of enrolment, never received any treatment, and was therefore excluded from toxicity analysis.
Targeted toxic effects: selected organ or infectious toxic effects with mandatory reporting of all grades.
Non-targeted toxic effects: required reporting of all grade 3–5 toxic effects.
Data were not reported regarding toxicity for three patients in the purged transplantation group and one patient in the non-purged transplantation group.
There were no non-targeted toxic effects of grades 3–5 that were noted in more than 5% of patients.