Table 2.
Adverse events and adverse drug reactions.
| AEs | ADRs | |||
|---|---|---|---|---|
| Incidence, N (%) | Events | Incidence, N (%) | Events | |
| Skin and subcutaneous tissue disorders | 149 (22.3) | 173 | 115 (17.2) | 135 |
| Rash | 82 (12.3) | 86 | 74 (11.1) | 78 |
| Pruritus | 41 (6.1) | 42 | 29 (4.3) | 29 |
| Alopecia | 8 (1.2) | 8 | 6 (0.9) | 6 |
| Gastrointestinal disorders | 89 (13.3) | 123 | 47 (7.0) | 61 |
| Nausea | 17 (2.5) | 19 | 13 (1.9) | 15 |
| Dyspepsia | 15 (2.2) | 15 | 6 (0.9) | 6 |
| Constipation | 14 (2.1) | 14 | 7 (1.0) | 7 |
| Abdominal pain | 12 (1.8) | 12 | 6 (0.9) | 6 |
| Abdominal pain upper | 10 (1.5) | 11 | 4 (0.6) | 5 |
| Diarrhea | 8 (1.2) | 9 | 4 (0.6) | 4 |
| Investigations | 75 (11.2) | 126 | 51 (7.6) | 88 |
| Alanine aminotransferase increased | 35 (5.2) | 35 | 25 (3.7) | 25 |
| Aspartate aminotransferase increased | 25 (3.7) | 26 | 17 (2.5) | 18 |
| Blood bilirubin increased | 16 (2.4) | 16 | 10 (1.5) | 10 |
| Platelet count decreased | 13 (1.9) | 14 | 10 (1.5) | 11 |
| Lipase increased | 7 (1.0) | 7 | 7 (1.0) | 7 |
| Weight decreased | 7 (1.0) | 7 | 4 (0.6) | 4 |
| Musculoskeletal and connective tissue disorders | 76 (11.4) | 82 | 41 (6.1) | 46 |
| Myalgia | 40 (6.0) | 42 | 27 (4.0) | 29 |
| Back pain | 9 (1.3) | 9 | 3 (0.4) | 3 |
| Pain in extremity | 7 (1.0) | 7 | 4 (0.6) | 4 |
| Infections and infestations | 62 (9.3) | 66 | 7 (1.0) | 7 |
| Upper respiratory tract infection | 33 (4.9) | 34 | 2 (0.3) | 2 |
| Nasopharyngitis | 8 (1.2) | 8 | 0 (0.0) | 0 |
| Blood and lymphatic system disorders | 59 (8.8) | 80 | 51 (7.6) | 69 |
| Thrombocytopenia | 35 (5.2) | 38 | 32 (4.8) | 35 |
| Neutropenia | 20 (3.0) | 20 | 19 (2.8) | 19 |
| Anemia | 8 (1.2) | 10 | 5 (0.7) | 5 |
| Nervous system disorders | 59 (8.8) | 64 | 41 (6.1) | 43 |
| Headache | 44 (6.6) | 44 | 34 (5.1) | 34 |
| Dizziness | 9 (1.3) | 9 | 4 (0.6) | 4 |
| General disorders and administration site conditions | 50 (7.5) | 57 | 30 (4.5) | 32 |
| Fatigue | 15 (2.2) | 15 | 13 (1.9) | 13 |
| Pyrexia | 11 (1.6) | 11 | 3 (0.4) | 3 |
| Metabolism and nutrition disorders | 38 (5.7) | 45 | 16 (2.4) | 17 |
| Decreased appetite | 12 (1.8) | 13 | 7 (1.0) | 8 |
| Hyperglycemia | 8 (1.2) | 8 | 3 (0.4) | 3 |
| Hypocalcemia | 7 (1.0) | 8 | 3 (0.4) | 3 |
| Hepatobiliary disorders | 29 (4.3) | 31 | 25 (3.7) | 27 |
| Hyperbilirubinemia | 21 (3.1) | 21 | 21 (3.1) | 21 |
| Eye disorders | 27 (4.0) | 29 | 11 (1.6) | 12 |
| Dry eye | 8 (1.2) | 8 | 4 (0.6) | 4 |
| Respiratory, thoracic, and mediastinal disorders | 25 (3.7) | 33 | 9 (1.3) | 9 |
| Cough | 8 (1.2) | 8 | 1 (0.1) | 1 |
| Dyspnea | 7 (1.0) | 8 | 3 (0.4) | 3 |
| Psychiatric disorders | 11 (1.6) | 14 | 1 (0.1) | 1 |
| Insomnia | 8 (1.2) | 8 | 1 (0.1) | 1 |
| Total | 410 (61.3) | 973 | 271 (40.5) | 559 |
Data presented only occurred 1.0% or more in AEs based on PT. Incidence (%): N/(N of safety evaluation patients)×100. Coding dictionary: MedDRA 19.1.
Abbreviations: ADRs, adverse drug reactions; AEs, adverse events; PT, preferred term.