Table 2.
AEs and laboratory data*
|
Placebo group (n = 54) |
E6011 100‐mg group (n = 28) |
E6011 200‐mg group (n = 54) |
E6011 400/200‐mg group (n = 54) |
E6011 total (n = 136) |
|
|---|---|---|---|---|---|
| All AEs | 34 (63.0) | 19 (67.9) | 38 (70.4) | 43 (79.6) | 100 (73.5) |
| Treatment‐related AEs | 12 (22.2) | 13 (46.4) | 18 (33.3) | 23 (42.6) | 54 (39.7) |
| AE maximum grade | |||||
| Grade 1 | 7 (13.0) | 4 (14.3) | 10 (18.5) | 9 (16.7) | 23 (16.9) |
| Grade 2 | 25 (46.3) | 13 (46.4) | 25 (46.3) | 32 (59.3) | 70 (51.5) |
| Grade 3 | 2 (3.7) | 1 (3.6) | 3 (5.6) | 0 | 4 (2.9) |
| Grade 4 | 0 | 1 (3.6) | 0 | 2 (3.7) | 3 (2.2) |
| Grade 5 | 0 | 0 | 0 | 0 | 0 |
| Serious AEs | 2 (3.7) | 1 (3.6) | 2 (3.7) | 3 (5.6) | 6 (4.4) |
| Death | 0 | 0 | 0 | 0 | 0 |
| AEs leading to withdrawal | 2 (3.7) | 1 (3.6) | 0 | 2 (3.7) | 3 (2.2) |
| AEs that occurred in ≥5% of patients in any group | |||||
| Nasopharyngitis | 16 (29.6) | 7 (25.0) | 10 (18.5) | 18 (33.3) | 35 (25.7) |
| URI | 2 (3.7) | 2 (7.1) | 4 (7.4) | 2 (3.7) | 8 (5.9) |
| Stomatitis | 1 (1.9) | 0 | 2 (3.7) | 5 (9.3) | 7 (5.1) |
| Bronchitis | 1 (1.9) | 2 (7.1) | 1 (1.9) | 3 (5.6) | 6 (4.4) |
| Back pain | 1 (1.9) | 1 (3.6) | 3 (5.6) | 2 (3.7) | 6 (4.4) |
| Pharyngitis | 2 (3.7) | 0 | 3 (5.6) | 2 (3.7) | 5 (3.7) |
| Dental caries | 0 | 0 | 0 | 3 (5.6) | 3 (2.2) |
| Headache | 3 (5.6) | 0 | 0 | 1 (1.9) | 1 (0.7) |
| Laboratory data | |||||
| Hemoglobin, gm/liter | −2.0 ± 9.7 | −1.6 ± 7.2 | 0.5 ± 10.3 | −3.3 ± 10.4 | −1.4 ± 9.9 |
| Lymphocytes, 109/liter | −0.05 ± 0.61 | 0.08 ± 0.38 | −0.01 ± 0.34 | −0.06 ± 0.57 | −0.01 ± 0.45 |
| Neutrophils, 109/liter | −0.09 ± 2.02 | −0.40 ± 1.42 | −0.34 ± 1.49 | −0.39 ± 2.22 | −0.37 ± 1.79 |
| ALT, units/liter | 0.6 ± 12.0 | 3.9 ± 26.5 | 3.4 ± 12.8 | 0.3 ± 14.1 | 2.3 ± 16.9 |
| Creatinine, μmoles/liter | 0.7 ± 5.7 | 1.9 ± 6.1 | 0.7 ± 5.2 | 2.0 ± 21.3 | 1.4 ± 14.0 |
| HDL cholesterol, mmoles/liter | −0.04 ± 0.28 | 0.05 ± 0.28 | 0.02 ± 0.24 | 0.05 ± 0.28 | 0.04 ± 0.26 |
| LDL cholesterol, mmoles/liter | 0.01 ± 0.44 | −0.05 ± 0.40 | −0.03 ± 0.55 | 0.03 ± 0.44 | −0.01 ± 0.48 |
| Creatine kinase, IU/liter | 5.4 ± 25.3 | 7.2 ± 26.4 | 2.1 ± 34.8 | 18.4 ± 74.0 | 9.6 ± 53.1 |
*
Adverse event (AE) values are the number (%) of patients. Laboratory data are the mean ± SD change from baseline at week 24 (using last observation carried forward). AEs emerged until week 24. However, for patients who discontinued the study drug during the treatment phase, AEs emerged until 70 days after the last intended dose. A patient with ≥2 AEs in the same preferred term was counted only once for that preferred term. MedDRA version 20.1 was used. URI = upper respiratory tract infection; ALT = alanine aminotransferase; HDL = high‐density lipoprotein; LDL = low‐density lipoprotein.