Table 2.

Subject incidence of TEAEs and TRAEs in all 110 patients treated with blinatumomab

TEAETRAE
n (%)95% CIn (%)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 
 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 
 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 
TEAETRAE
n (%)95% CIn (%)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 
 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 
 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 

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.

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