Table 4.
Single ASCT (control) | 1st ASCT (tandem) | 2nd ASCT (tandem) | ||||
---|---|---|---|---|---|---|
Event | Any grade | Grade ≥ 3 | Any grade | Grade ≥ 3 | Any grade | Grade ≥ 3 |
Hematologic adverse events | ||||||
Neutropenia | 256/256 (100%) | 256/256 (100%) | 117/117 (100%) | 117/117 (100%) | 117/117 (100%) | 117/117 (100%) |
Thrombocytopenia | 256/256 (100%) | 256/256 (100%) | 117/117 (100%) | 117/117 (100%) | 117/117 (100%) | 117/117 (100%) |
Anaemia | 256/256 (100%) | 96/256 (37.5%) | 117/117 (100%) | 65/117 (55.6%) | 117/117 (100%) | 56/117 (47.9%) |
Gastrointestinal adverse events | ||||||
Nausea | 225/247 (91.1%) | 69/247 (27.9%) | 112/115 (97.4%) | 33/115 (28.7%) | 110/117 (94.0%) | 39/117 (33.3%) |
Vomit | 117/261 (44.8%) | 17/261 (6.5%) | 70/117 (59.8%) | 3/117 (2.6%) | 75/112 (67.0%) | 5/112 (4.5%) |
Stomatitis | 213/234 (91.0%) | 36/234 (15.4%) | 77/114 (67.5%) | 13/114 (11.4%) | 81/114 (71.1%) | 5/114 (4.4%) |
Constipation | 8/242 (3.3%) | 0/242 (0%) | 11/115 (9.5%) | 0/115 (0%) | 15/112 (13.4%) | 0/112 (0%) |
Diarrhoea | 226/246 (91.9%) | 97/246 (39.4%) | 100/113 (88.5%) | 22/113 (19.5%) | 91/112 (81.2%) | 21/112 (18.8%) |
Hepatobiliary adverse events | ||||||
Hyperbilirubinaemia | 23/256 (9.0%) | 3/256 (1.2%) | 11/116 (9.5%) | 0/116 (0%) | 14/115 (12.2%) | 0/115 (0%) |
Elevated transaminases | 41/256 (16.0%) | 0/256 (0%) | 43/117 (36.8%) | 3/117 (2.6%) | 28/115 (24.3%) | 2/115 (1.7%) |
Nephrologic adverse events | ||||||
Azotaemia | 16/256 (6.1%) | 4/256 (1.6%) | 10/116 (8.6%) | 2/116 (1.7%) | 9/115 (7.8%) | 0/115 (0%) |
Febrile neutropenia | 145/256 (56.7%) | 145/256 (56.7%) | 66/117 (56.4%) | 66/117 (56.4%) | 59/117 (50.4%) | 59/117 (50.4%) |
Sinusoidal obstruction syndrome | 0/256 (0%) | 0/256 (0%) | 0/117 (0%) | 0/117 (0%) | 1/117 (0.9%) | 0/117 (0%) |
ASCT, autologous stem cell transplantation.