Table 2.
Treatment Emergent Adverse Events of All Causality With a Frequency > 10% in Phase 2 Patients
| Adverse Event (n = 107) | Grade |
|||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| 1 |
2 |
3 |
4 |
All |
||||||
| No. | % | No. | % | No. | % | No. | % | No. | % | |
| Fatigue | 13 | 12.1 | 12 | 11.2 | 2 | 1.9 | 0 | 27 | 25.2 | |
| Decreased appetite | 13 | 12.1 | 8 | 7.5 | 1 | 0.9 | 1 | 0.9 | 23 | 21.5 |
| Headache | 11 | 10.3 | 7 | 6.5 | 2 | 1.9 | 0 | 20 | 18.7 | |
| Muscle spasm | 13 | 12.1 | 5 | 4.7 | 2 | 1.9 | 0 | 20 | 18.7 | |
| Back pain | 3 | 2.8 | 10 | 9.3 | 5 | 4.7 | 1 | 0.9 | 19 | 17.8 |
| Constipation | 10 | 9.3 | 8 | 7.5 | 1 | 0.9 | 0 | 19 | 17.8 | |
| Dyspnea | 7 | 6.5 | 7 | 6.5 | 3 | 2.8 | 1 | 0.9 | 19* | 17.8 |
| Vomiting | 9 | 8.4 | 7 | 6.5 | 3 | 2.8 | 0 | 19 | 17.8 | |
| Cough | 13 | 12.1 | 4 | 3.7 | 0 | 0 | 17 | 15.9 | ||
| Nausea | 9 | 8.4 | 6 | 5.6 | 1 | 0.9 | 0 | 16 | 15 | |
| Pyrexia | 14 | 13.1 | 2 | 1.9 | 0 | 0 | 16 | 15 | ||
| Chest pain | 3 | 2.8 | 8 | 7.5 | 3 | 2.8 | 1 | 0.9 | 15 | 14 |
| Diarrhea | 14 | 13.1 | 1 | 0.9 | 0 | 0 | 15 | 14 | ||
| Anemia | 1 | 0.9 | 8 | 7.5 | 3 | 2.8 | 2 | 1.9 | 14 | 13.1 |
| Ocular hyperemia | 12 | 11.2 | 2 | 1.9 | 0 | 0 | 14 | 13.1 | ||
| Asthenia | 8 | 7.5 | 4 | 3.7 | 1 | 0.9 | 0 | 13 | 12.1 | |
| Hyperglycemia | 7 | 6.5 | 3 | 2.8 | 3 | 2.8 | 0 | 13 | 12.1 | |
| Weight decrease | 7 | 6.5 | 6 | 5.6 | 0 | 0 | 13 | 12.1 | ||
| Thrombocytopenia | 6 | 5.6 | 1 | 0.9 | 2 | 1.9 | 3 | 2.8 | 12 | 11.2 |
| Arthralgia | 5 | 4.7 | 3 | 2.8 | 3 | 2.8 | 0 | 11 | 10.3 | |
| Musculoskeletal pain | 4 | 3.7 | 7 | 6.5 | 1 | 0.9 | 0 | 11 | 10.3 | |
*
One grade 5 event of dyspnea attributed to disease progression was reported.