Table 6.
Frequency of complications in other studies.
| EPIC (16,28) | ESCALATOR (15,25) | Cappellini et al (26) | Piga et al (27) | Cappellini et al (14,30) | |
|---|---|---|---|---|---|
| Rash | 129 (11.5%) | 19 (8%) | 23 (4.9%) | 9 (5.4%) | 25 (8.4%) |
| Diarrhea | 87 (7.8%) | 14 (6%) | 40 (8.5%) | 35 (11.8%) | |
| Abd. Pain | 77 (4.8%) | 14 (6%) | 62 (13%) | 12 (7.1%) | 23 (7.8%) |
| Nausea&Vomiting | 62 (5.6%) | 38 (16.1%) | 87 (22.5%) | 22(13.1%) | 61 (20.6%) |
| Increased in serum Cr >33% BL | 552 (31.7%)a | 73 (30.9%) | 113 (38.2%) | ||
| 9 (3.8%)c | |||||
| Increased in serum Cr>33% BL &>ULN | 37 (3.9%)b | 6 (2.5%) | 34 (7.2%) | 13 (7.7%) | |
| 175 (10%)a | |||||
| Increased serum ALT> 10×ULN | 7 (0.6%) | 13 (5.5%) | 29 (6.1%) | 11 (6.6%) | 25 (8.4%)d |
a.
Transfusion dependent patients
b.
major Thalasemia patients
c.
This complication specified to drug in 9 patients out of 73 due to physician judgment.there was not any other explanation.
d.
Definition of liver dysfunction in this study: ALT was 5 folds above normal