Table 4.
AE (≥15% in either treatment group) regardless of relationship to study drug at the final assessment (safety population)
| Category, n (%) | Eltrombopag (n = 177) | Placebo (n = 177) | ||
|---|---|---|---|---|
| All AE | 177 (100) | 173 (98) | ||
| Suspected related to treatment* | 63 (36) | 42 (24) | ||
| Serious AE | 128 (72) | 100 (56) | ||
| Suspected related to treatment* | 26 (15) | 4 (2) | ||
| Bleeding AE | 74 (42) | 74 (42) | ||
| Grade 3/4 | 11 (6) | 14 (8) | ||
| Preferred term | All grades, n (%) | Grade 3/4, n (%) | All grades, n (%) | Grade 3/4, n (%) |
| Febrile neutropenia | 55 (31) | 47 (27) | 38 (21) | 32 (18) |
| Nausea | 54 (31) | 1 (<1) | 46 (26) | 1 (<1) |
| Neutropenia | 54 (31) | 50 (28) | 46 (26) | 46 (26) |
| Pyrexia | 53 (30) | 12 (7) | 46 (26) | 5 (3) |
| Constipation | 48 (27) | 2 (1) | 57 (32) | 2 (1) |
| Diarrhea | 44 (25) | 6 (3) | 25 (14) | 1 (<1) |
| Anemia | 35 (20) | 30 (17) | 26 (15) | 20 (11) |
| Vomiting | 33 (19) | 0 | 29 (16) | 1 (<1) |
| Asthenia | 31 (18) | 7 (4) | 34 (19) | 6 (3) |
| Fatigue | 31 (18) | 4 (2) | 27 (15) | 1 (<1) |
| Pneumonia | 30 (17) | 21 (12) | 25 (14) | 10 (6) |
| Decreased appetite | 27 (15) | 3 (2) | 21 (12) | 1 (<1) |
| Cough | 23 (13) | 0 | 29 (16) | 1 (<1) |
AEs with an absolute difference ≥5% between treatment groups are indicated in bold face type.
*
According to the investigator.