Table 3.
Adverse events (AEs) observed during the study
| 12.5 mg (N = 12) | 25 mg (N = 14) | 37.5 mg (N = 12) | |
|---|---|---|---|
| Adverse events with ≥2 patients in any group, n (%) | 6 (50 %) | 7 (50 %) | 9 (75 %) |
| Back pain | 1 (8 %) | 0 | 4 (33 %) |
| Pyrexia | 0 | 3 (21 %) | 2 (17 %) |
| Postoperative fever | 3 (25 %) | 0 | 2 (17 %) |
| Pleural effusion | 2 (17 %) | 0 | 2 (17 %) |
| Abdominal distension | 1 (8 %) | 0 | 2 (17 %) |
| Ascites | 1 (8 %) | 0 | 2 (17 %) |
| Procedural pain | 2 (17 %) | 0 | 1 (8 %) |
| ALT increased | 2 (17 %) | 1 (7 %) | 0 |
| AST increased | 2 (17 %) | 1 (7 %) | 0 |
| All grade 3 or 4 adverse events, n (%) | 0 | 0 | 1 (8 %) |
| All drug-related adverse events, n (%) | 1 (8 %) | 4 (29 %) | 4 (33 %) |
| Diarrhea | 0 | 1 (7 %) | 1 (8 %) |
| Renal impairment | 0 | 1 (7 %) | 1 (8 %) |
| Abdominal distension | 0 | 0 | 1 (8 %) |
| Abdominal pain | 0 | 0 | 1 (8 %) |
| Back pain | 0 | 0 | 1 (8 %) |
| Eosinophilia | 0 | 0 | 1 (8 %) |
| Eosinophil count increased | 0 | 0 | 1 (8 %) |
| Anorexia | 0 | 0 | 1 (8 %) |
| Pleural effusion | 0 | 0 | 1 (8 %) |
| Pain in extremity | 0 | 1 (7 %) | 0 |
| Vomiting | 0 | 1 (7 %) | 0 |
| Urinary tract infection | 0 | 1 (7 %) | 0 |
| Supraventricular extrasystoles | 1 (8 %) | 0 | 0 |
| Serious adverse events, n (%) | 0 | 0 | 2 (17 %) |
| Ascites | 0 | 0 | 1 (8 %) |
| Pleural effusion | 0 | 0 | 1a (8 %) |
| Portal vein thrombosis | 0 | 0 | 1a (8 %) |
| Death, n (%) | 0 | 0 | 1b (8 %) |
The severity of adverse events was graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (version 1.9, dated December 2004). The data include AEs seen on study plus all drug-related AEs
ALT alanine aminotransferase, AST aspartate aminotransferase
aOne patient experienced pleural effusion and portal vein thrombosis 22 days post-treatment
bThe death occurred 149 days after the end of treatment with eltrombopag