Table 2.
Summary of AEs and ADRs during the treatment period
| Bilayer tablets | IR capsules | |
|---|---|---|
| N | 126 | 125 |
| AEs | 97 (77.0) | 101 (80.8) |
| Severe AEs | 6 (4.8) | 7 (5.6) |
| AEs resulting in death | 4 (3.2) | 3 (2.4) |
| Serious AEs | 11 (8.7) | 17 (13.6) |
| AEs resulting in discontinuation of the study drug | 15 (11.9) | 25 (20.0) |
| AEs leading to dose reduction of the study drug | 1 (0.8) | 0 |
| ADRs | 74 (58.7) | 67 (53.6) |
| Severe ADRs | 1 (0.8) | 0 |
| ADRs resulting in death | 0 | 0 |
| Serious ADRs | 2 (1.6) | 0 |
| ADRs resulting in discontinuation of the study drug | 10 (7.9) | 11 (8.8) |
| ADRs leading to dose reduction of the study drug | 0 | 0 |
| AEs in ≥ 2% of patients during the treatment period, by preferred term (MedDRA/J version 23.0)a | ||
| Nausea | 41 (32.5) | 44 (35.2) |
| Constipation | 28 (22.2) | 21 (16.8) |
| Vomiting | 26 (20.6) | 26 (20.8) |
| Somnolence | 18 (14.3) | 12 (9.6) |
| Decreased appetite | 16 (12.7) | 5 (4.0) |
| Dizziness | 10 (7.9) | 6 (4.8) |
| Malaise | 7 (5.6) | 2 (1.6) |
| Diarrhea | 6 (4.8) | 5 (4.0) |
| Neutrophil count decreased | 4 (3.2) | 2 (1.6) |
| Stomatitis | 3 (2.4) | 2 (1.6) |
| White blood cell count decreased | 3 (2.4) | 3 (2.4) |
| Gastric cancer | 3 (2.4) | 1 (0.8) |
| Pruritus | 2 (1.6) | 3 (2.4) |
| Pancreatic carcinoma | 1 (0.8) | 3 (2.4) |
| Oropharyngeal pain | 1 (0.8) | 3 (2.4) |
| Edema peripheral | 0 | 3 (2.4) |
| Metastases to liver | 0 | 3 (2.4) |
| Fall | 0 | 3 (2.4) |
| Bone marrow failure | 0 | 3 (2.4) |
Values are n (%) of patients
aOrdered by descending frequency in the bilayer tablet group
ADR adverse drug reaction, AE adverse event, IR immediate-release