Table 3.
Comparison of adverse events occurred in 10% or more patients during the first eight weeks post-infusion between EMM and non-EMM patients in two clinical trials conducted in our center.
| EMM (n = 25) | non-EMM (n = 36) | p-Value | |||||||
|---|---|---|---|---|---|---|---|---|---|
| Adverse event | Grade 1-2n (%) | Grade 3n (%) | Grade 4n (%) | Any Graden (%) | Grade 1-2n (%) | Grade 3n (%) | Grade 4n (%) | Any Graden (%) | |
| Hematologic | |||||||||
| Leukopenia | 1 (4.0) | 1 (4.0) | 23 (92.0) | 25 (100.0) | 1 (2.8) | 1 (2.8) | 34 (94.4) | 36 (100.0) | 1.000 |
| Neutropenia | 1 (4.0) | 2 (8.0) | 22 (88.0) | 25 (100.0) | 0 (0.0) | 1 (2.8) | 35 (97.2) | 36 (100.0) | 0.410 |
| Lymphopenia | 0 (0.0) | 0 (0.0) | 25 (100.0) | 25 (100.0) | 0 (0.0) | 0 (0.0) | 36 (100.0) | 36 (100.0) | – |
| Anemia | 6 (24.0) | 15 (60.0) | 2 (8.0) | 23 (92.0) | 4 (11.1) | 28 (77.8) | 4 (11.1) | 36 (100.0) | 0.056 |
| Thrombocytopenia | 6 (24.0) | 3 (12.0) | 16 (64.0) | 25 (100.0) | 4 (11.1) | 3 (8.3) | 29 (80.6) | 36 (100.0) | 0.292 |
| Coagulative | |||||||||
| Prolonged APTT | 17 (68.0) | 0 (0.0) | 0 (0.0) | 17 (68.0) | 28 (77.8) | 1 (2.8) | 0 (0.0) | 29 (80.6) | 1.000 |
| Fibrogenopenia | 4 (16.0) | 1 (4.0) | 0 (0.0) | 5 (20.0) | 15 (41.7) | 2 (5.6) | 0 (0.0) | 17 (47.2) | 1.000 |
| Metabolic | |||||||||
| Hypokalemia | 18 (72.0) | 0 (0.0) | 0 (0.0) | 18 (72.0) | 19 (52.8) | 3 (8.3) | 0 (0.0) | 22 (61.1) | 0.262 |
| Hyponatremia | 8 (32.0) | 2 (8.0) | 0 (0.0) | 10 (40.0) | 12 (33.3) | 1 (2.8) | 1 (2.8) | 14 (38.9) | 1.000 |
| Hypocalcemia | 14 (56.0) | 1 (4.0) | 0 (0.0) | 15 (60.0) | 20 (55.6) | 0 (0.0) | 0 (0.0) | 20 (55.6) | 0.410 |
| Elevated ALT | 7 (28.0) | 2 (8.0) | 0 (0.0) | 9 (36.0) | 11 (30.6) | 1 (2.8) | 0 (0.0) | 12 (33.3) | 0.562 |
| Elevated AST | 6 (24.0) | 2 (8.0) | 0 (0.0) | 8 (32.0) | 13 (36.1) | 3 (8.3) | 0 (0.0) | 16 (50.0) | 1.000 |
| Heart failure | 4 (16.0) | 0 (0.0) | 2 (8.0) | 6 (24.0) | 8 (22.2) | 0 (0.0) | 1 (2.8) | 9 (25.0) | 0.562 |
| Arrhythmia | 5 (20.0) | 3 (12.0) | 0 (0.0) | 8 (32.0) | 9 (25.0) | 0 (0.0) | 0 (0.0) | 9 (25.0) | 0.064 |
| Creatinine increased | 3 (12.0) | 2 (8.0) | 0 (0.0) | 5 (20.0) | 3 (8.3) | 1 (2.8) | 0 (0.0) | 4 (11.1) | 0.562 |
| Others | |||||||||
| Fever | 16 (64.0) | 3 (12.0) | 0 (0.0) | 19 (76.0) | 26 (72.2) | 6 (16.7) | 0 (0.0) | 32 (88.9) | 0.725 |
| Lung infection | 0 (0.0) | 9 (36.0) | 0 (0.0) | 9 (36.0) | 3 (8.3) | 17 (47.2) | 1 (2.8) | 21 (58.3) | 0.307 |
| Upper respiratory infection | 3 (12.0) | 1 (4.0) | 0 (0.0) | 4 (16.0) | 3 (8.3) | 0 (0.0) | 0 (0.0) | 3 (8.3) | 0.410 |
APTT, activated partial thrombin time; ALT, alanine aminotransferase; AST, aspartate aminotransferase. The grading of AE was according to the CTCAE 4.03. The P value is based on Fisher’s exact test, or Pearson’s chi-squared test. P values less than 0.05 (two-tailed) were considered statistically significant.