The number and proportion of grade 3 or greater AEs based on treatment phase
| Number of events (number of patients) . | Induction (n, %) . | Maintenance (n, %) . | Follow-up (n, %) . |
|---|---|---|---|
| Grade ≥3 AEs∗ | |||
| N = 248 (156) | 163 (66) | 33 (13) | 52 (21) |
| Serious† and treatment related, 89 (70) | 56 of 163 (34) | 18 of 33 (54) | 15 of 53 (28) |
| Grade ≥3 infections | |||
| n = 91 (77) | 45 of 91 (49) | 19 of 91 (21) | 27 of 91 (30) |
| Serious and treatment related, n = 40 (39) | 21 of 91 (23) | 12 of 91 (13) | 7 of 91 (8) |
| Grade 5 events (infections [n] in brackets) | |||
| N = 91 (infections, n, in brackets) | 13 | 7 | 71 |
| Causality | |||
| Bendamustine | 6 (5) | 0 | 3 |
| Rituximab | 0 | 1 (1) | 1 (1) |
| Lymphoma | 7 | 5 | 31 (5) |
| Unrelated | 0 | 1 | 30 (10) |
| Subsequent treatment | NA | 6 (4) | |
| Impact on treatment | |||
| Dose reduction, no delay | 8 of 196 (4) | ||
| Dose reduction and delay | 17 of 196 (9) | ||
| Treatment stopped | 43 of 196 (22) | ||
| Number of events (number of patients) . | Induction (n, %) . | Maintenance (n, %) . | Follow-up (n, %) . |
|---|---|---|---|
| Grade ≥3 AEs∗ | |||
| N = 248 (156) | 163 (66) | 33 (13) | 52 (21) |
| Serious† and treatment related, 89 (70) | 56 of 163 (34) | 18 of 33 (54) | 15 of 53 (28) |
| Grade ≥3 infections | |||
| n = 91 (77) | 45 of 91 (49) | 19 of 91 (21) | 27 of 91 (30) |
| Serious and treatment related, n = 40 (39) | 21 of 91 (23) | 12 of 91 (13) | 7 of 91 (8) |
| Grade 5 events (infections [n] in brackets) | |||
| N = 91 (infections, n, in brackets) | 13 | 7 | 71 |
| Causality | |||
| Bendamustine | 6 (5) | 0 | 3 |
| Rituximab | 0 | 1 (1) | 1 (1) |
| Lymphoma | 7 | 5 | 31 (5) |
| Unrelated | 0 | 1 | 30 (10) |
| Subsequent treatment | NA | 6 (4) | |
| Impact on treatment | |||
| Dose reduction, no delay | 8 of 196 (4) | ||
| Dose reduction and delay | 17 of 196 (9) | ||
| Treatment stopped | 43 of 196 (22) | ||