Subject incidence of TEAEs and TRAEs in all 110 patients treated with blinatumomab
. | TEAE . | TRAE . | ||
---|---|---|---|---|
n (%) . | 95% CI . | n (%) . | 95% CI . | |
Patients reporting AEs | ||||
Any grade | 109 (99.1) | 95.0-100.0 | 81 (73.6) | 64.4-81.6 |
Grade 3 | 71 (64.5) | 54.9-73.4 | 29 (26.4) | 18.4-35.6 |
Grade 4 | 31 (28.2) | 20.0-37.6 | 3 (2.7) | 0.6-7.8 |
Serious | 50 (45.5) | 35.9-55.2 | 21 (19.1) | 12.2-27.7 |
Fatal | 9 (8.2) | 3.8-15.0 | 0 | 0 |
Leading to treatment discontinuation | 7 (6.4) | 2.6-12.7 | 4 (3.6) | 1.0-9.0 |
Serious | 6 (5.5) | 2.0-11.5 | 4 (3.6) | 1.0-9.0 |
Fatal | 2 (1.8)] | 0.2-6.4 | 0 | 0 |
Leading to treatment interruption | 25 (22.7) | 15.3–31.7 | 18 (16.4) | 10.0-24.6 |
Serious | 17 (15.5) | 9.3–23.6 | 11 (10.0) | 5.1-17.2 |
Fatal | 3 (2.7) | 0.6-7.8 | 0 | 0 |
. | TEAE . | TRAE . | ||
---|---|---|---|---|
n (%) . | 95% CI . | n (%) . | 95% CI . | |
Patients reporting AEs | ||||
Any grade | 109 (99.1) | 95.0-100.0 | 81 (73.6) | 64.4-81.6 |
Grade 3 | 71 (64.5) | 54.9-73.4 | 29 (26.4) | 18.4-35.6 |
Grade 4 | 31 (28.2) | 20.0-37.6 | 3 (2.7) | 0.6-7.8 |
Serious | 50 (45.5) | 35.9-55.2 | 21 (19.1) | 12.2-27.7 |
Fatal | 9 (8.2) | 3.8-15.0 | 0 | 0 |
Leading to treatment discontinuation | 7 (6.4) | 2.6-12.7 | 4 (3.6) | 1.0-9.0 |
Serious | 6 (5.5) | 2.0-11.5 | 4 (3.6) | 1.0-9.0 |
Fatal | 2 (1.8)] | 0.2-6.4 | 0 | 0 |
Leading to treatment interruption | 25 (22.7) | 15.3–31.7 | 18 (16.4) | 10.0-24.6 |
Serious | 17 (15.5) | 9.3–23.6 | 11 (10.0) | 5.1-17.2 |
Fatal | 3 (2.7) | 0.6-7.8 | 0 | 0 |
Retreatment data (treated as cycle 2) for 1 patient is included. Adverse events coded using MedDRA version 22.1. Severity graded using CTCAE v4.03.