Table 4.
Episodes of Grade 3, 4, or 5 Toxicity (CTCAE; version 4.0)
| IVIG+ (N=38)* Number of episodes (%) |
NO-IVIG (N=25) Number of episodes (%) |
|
|---|---|---|
|
| ||
| Hematopoietic | ||
| Anemia | 4 (10·5%) | 3 (12·0%) |
| Leukopenia | 1 (2·6%) | 1 (4·0%) |
| Neutropenia | 5 (13·2%) | 4 (16·0%) |
| Thrombocytopenia | 2 (5·3%) | 2 (8·0%) |
| Febrile neutropenia | 1 (2·6%) | 1 (4·0%) |
| Other | 1 (2·6%) | 1 (4·0%) |
|
| ||
| Gastrointestinal | ||
| ALT increased | 1 (2·6%) | |
| AST increased | 1 (2·6%) | |
| Intra-abdominal hemorrhage | 1 (4·0%) | |
| Mucositis | 1 (4·0%) | |
| Nausea | 1 (4·0%) | |
| Vomiting | 4 (10·5%) | 1 (4·0%) |
| Colitis | 1 (4·0%) | |
| Diarrhea | 1 (2·6%) | |
|
| ||
| Infectious diseses | ||
| Bladder infection | 2 (5·3%) | 1 (4·0%) |
| Fever | 1 (2·6%) | |
| Catheter related | 3 (7·9%) | 2 (8·0%) |
| Enterocolitis | 1 (2·6%) | 1 (4·0%) |
| Lung infection | 1 (4·0%) | |
| Other | 6 (15·8%) | 5 (20·0%) |
|
| ||
| Nervous system | ||
| Irritability | 1 (2·6%) | 1 (4·0%) |
| Nystagmus | 2 (5·3%) | 3 (12·0%) |
| Ataxia | 1 (2·6%) | 3 (12·0%) |
| Agitation | 7 (18·4%) | 7 (28·0%) |
| Personality changes | 1 (2·6%) | |
|
| ||
| Cardiovascular | ||
| Hypertension | 2 (5·3%) | 2 (8·0%) |
|
| ||
| Metabolism and Nutrition | ||
| Anorexia | 1 (2·6%) | |
| Weight gain | 1 (2·6%) | 1 (4·0%) |
| Dehydration | 1 (2·6%) | 1 (4·0%) |
| Hyperglycemia | 2 (5·3%) | 2 (8·0%) |
| Hypoalbuminemia | 1 (2·6%) | |
| Hypoglycemia | 1 (2·6%) | |
| Hypokalemia | 2 (5·3%) | 2 (8·0%) |
| Hyponatremia | 1 (4·0%) | |
| Hypophosphatemia | 1 (2·6%) | 2 (8·0%) |
|
| ||
| Respiratory | ||
| Hypoxemia | 1 (4·0%) | |
*
The IVIG+ arm also contains patients that crossed over from the NO-IVIG arm