Table 4.
AEs within 10 weeks since treatment and within 24-week treatment
| AE | Within 10 weeks since treatment | Within 24-week treatment | |||
|---|---|---|---|---|---|
| HETROM-2.5, n = 168 | HETROM-5, n = 171 | Placebo, n = 85 | Hetrombopag, n = 339 | Placebo-Eltrombopag, n = 85 | |
| Any AE, n (%) | 154 (91.7) | 162 (94.7) | 81 (95.3) | 332 (97.9) | 85 (100.0) |
| AEs leading to dose discontinuation, n (%) | 2 (1.2) | 2 (1.2) | 4 (4.7) | 11 (3.2) | 7 (8.2) |
| AEs leading to dose interruption or reduction, n (%) | 6 (3.6) | 30 (17.5) | 1 (1.2) | 47 (13.9) | 7 (8.2) |
| AESI, n (%) | 0 | 0 | 0 | 2 (0.6) | 1 (1.2) |
| Most common AEs (≥ 10% of patients in either treatment group), n (%) | |||||
| Upper respiratory tract infection | 44 (26.2) | 45 (26.3) | 29 (34.1) | 143 (42.2) | 39 (45.9) |
| Urinary tract infection | 20 (11.9) | 28 (16.4) | 14 (16.5) | 58 (17.1) | 18 (21.2) |
| Platelet count increased | 4 (2.4) | 24 (14.0) | 2 (2.4) | 39 (11.5) | 7 (8.2) |
| Blood urine present | 24 (14.3) | 21 (12.3) | 11 (12.9) | 49 (14.5) | 13 (15.3) |
| Blood lactate dehydrogenase increased | 12 (7.1) | 21 (12.3) | 6 (7.1) | 40 (11.8) | 9 (10.6) |
| Immune thrombocytopenic purpura | 23 (13.7) | 21 (12.3) | 25 (29.4) | 58 (17.1) | 28 (32.9) |
| Red blood cells urine positive | 24 (14.3) | 14 (8.2) | 13 (15.3) | 47 (13.9) | 17 (20.0) |
| Alanine aminotransferase increased | 11 (6.5) | 13 (7.6) | 8 (9.4) | 32 (9.4) | 16 (18.8) |
| Diarrhea | 17 (10.1) | 13 (7.6) | 1 (1.2) | 39 (11.5) | 3 (3.5) |
| Gingival bleeding | 11 (6.5) | 13 (7.6) | 9 (10.6) | 32 (9.4) | 11 (12.9) |
| Headache | 13 (7.7) | 12 (7.0) | 8 (9.4) | 33 (9.7) | 9 (10.6) |
| Hypokalemia | 7 (4.2) | 10 (5.8) | 14 (16.5) | 24 (7.1) | 14 (16.5) |
| Protein urine present | 11 (6.5) | 7 (4.1) | 8 (9.4) | 19 (5.6) | 9 (10.6) |
| Hepatic function abnormal | 3 (1.8) | 4 (2.3) | 6 (7.1) | 16 (4.7) | 10 (11.8) |
| Any SAE, n (%) | 16 (9.5) | 15 (8.8) | 17 (20.0) | 49 (14.5) | 21 (24.7) |
| Most common SAEs (≥ 2 patients in either treatment group), n (%) | |||||
| Thrombocytopenia* | 15 (8.9) | 9 (5.3) | 16 (18.8) | 34 (10.0) | 18 (21.2) |
| Gastrointestinal hemorrhage | 3 (1.8) | 0 | 0 | 3 (0.9) | 0 |
| Cerebral hemorrhage | 2 (1.2) | 0 | 0 | 2 (0.6) | 0 |
| Death, n (%) | 1 (0.6) | 1 (0.6) | 1 (1.2) | 2 (0.6) | 1 (1.2) |
HETROM-2.5, dosage was titrated from an initial dose of once-daily 2.5 mg hetrombopag; HETROM-5, dosage was titrated from an initial dose of once-daily 5 mg hetrombopag; *thrombocytopenia was defined as platelet count was decreased compared with that observed at baseline. AE, adverse event; SAE, serious adverse event