Table 2.
Adverse events (grade ≥3) regardless of causality
| Adverse events | Topp et al50 (21 patients) |
Topp et al53,54 (189 patients) |
|---|---|---|
| Peripheral blood | ||
| Leukopenia | 2 (9.5%) | 15 (7.9%) |
| Neutropenia | 1 (4.8%) | 30 (15.8%) |
| Thrombopenia | 1 (4.8%) | 16 (8.4%) |
| Investigations | ||
| ALT increased | 1 (4.8%) | 13 (6.8%) |
| Ig decreased | 5 (23.8%) | ND |
| Infections | ||
| Bacterial sepsis | 1 (4.8%) | 15 (7.9%) |
| Bronchopneumonia | 1 (4.8%) | 17 (8.9%) |
| Neurologic events | ||
| Syncope/convulsion | 1 (4.8%) | 2 (1%) |
| Encephalopathy | ND | 6 (3.1%) |
| Somnolence | 1 (4.8%) | 1 (<1%) |
| Metabolism disorders | ||
| Hypokalemia | 1 (4.8%) | 13 (6.8%) |
| Hypophosphatemia | ND | 10 (5.2%) |
Abbreviations: ALT, alanine aminotransferase; Ig, immunoglobulin; ND, not done.