Table II.
Adverse events and significant adverse events.
| All AE* |
SigAE |
|||
|---|---|---|---|---|
| Adverse event | n=642 | % | n=93 | % |
| Dermatologic | 16 | 2.49 | 0 | 0.00 |
| Alopecia | 3 | 0.47 | 0 | 0.00 |
| Rash | 6 | 0.93 | 0 | 0.00 |
| Photosensitivity | 1 | 0.16 | 0 | 0.00 |
| Nodulosis | 7 | 1.09 | 0 | 0.00 |
| Gastrointestinal | 79 | 12.31 | 11 | 11.83 |
| Oral Ulcers/Stomatitis | 19 | 2.96 | 1 | 1.08 |
| N/ V/ Anorexia/ Dyspepsia | 54 | 8.41 | 7 | 7.53 |
| Diarrhea | 11 | 1.71 | 3 | 3.23 |
| Haematologic | 195 | 30.37 | 20 | 21.51 |
| Leukopenia | 13 | 2.02 | 0 | 0.00 |
| Thrombocytopenia | 6 | 0.93 | 1 | 1.08 |
| Anaemia | 179 | 27.88 | 19 | 20.43 |
| Hepatic | 168 | 26.17 | 17 | 18.28 |
| Transaminitis | 168 | 26.17 | 17 | 18.28 |
| Fibrosis | 0 | 0.00 | 0 | 0.00 |
| Cirrhosis | 0 | 0.00 | 0 | 0.00 |
| Infectious Disease | 81 | 12.62 | 12 | 12.90 |
| Central Nervous System | 15 | 2.34 | 1 | 1.08 |
| Headache | 4 | 0.62 | 0 | 0.00 |
| Dizziness/Vertigo | 1 | 0.16 | 0 | 0.00 |
| Fatigue/Malaise | 9 | 1.40 | 1 | 1.08 |
| Depression/Mood | 1 | 0.16 | 0 | 0.00 |
| Memory Impairment | 1 | 0.16 | 0 | 0.00 |
| Respiratory | 45 | 7.01 | 21 | 22.58 |
| Dry Cough | 15 | 2.34 | 5 | 5.38 |
| Dyspnea | 21 | 3.27 | 8 | 8.60 |
| Interstitial Lung Disease | 26 | 4.05 | 14 | 15.05 |
| Other | 46 | 7.17 | 11 | 11.83 |
*
AE: adverse events; SigAE: significant AE; N: nausea; V: vomiting.