Table 2.
Treatment-related adverse events occurring in >10% of 36 AE-evaluable patients
| Adverse Event, n (%) | Grade 1 | Grade 2 | Grade 3 | Grade 4 | Total no. patients with any grade |
|---|---|---|---|---|---|
| Diarrhea | 14 (39%) | 5 (14%) | 4 (11%) | 0 (0%) | 23 (64%) |
| Thrombocytopenia | 9 (25%) | 9 (25%) | 1 (3%) | 0 (0%) | 19 (53%) |
| Fatigue | 13 (36%) | 4 (11%) | 1 (3%) | 0 (0%) | 18 (50%) |
| Hyperglycemia | 3 (8%) | 7 (19%) | 4 (11%) | 0 (0%) | 14 (39%) |
| Rash/Pruritis/Dermatitis | 4 (11%) | 3 (8%) | 7 (19%) | 0 (0%) | 14 (39%) |
| Dyspepsia/GERD | 9 (25%) | 3 (8%) | 1 (3%) | 0 (0%) | 13 (36%) |
| Anorexia | 4 (11%) | 5 (14%) | 2 (6%) | 0 (0%) | 11 (31%) |
| Nausea | 7 (19%) | 2 (6%) | 1 (3%) | 0 (0%) | 10 (28%) |
| Bruising | 8 (22%) | 1 (3%) | 0 (0%) | 0 (0%) | 9 (25%) |
| Elevated Bilirubin | 2 (6%) | 6 (17%) | 1 (3%) | 0 (0%) | 9 (25%) |
| Muscle Cramping | 5 (14%) | 4 (11%) | 0 (0%) | 0 (0%) | 9 (25%) |
| ALT Elevated | 6 (17%) | 0 (0%) | 2 (6%) | 0 (0%) | 8 (22%) |
| Mood Disturbances | 1 (3%) | 4 (11%) | 3 (8%) | 0 (0%) | 8 (22%) |
| AST Elevated | 4 (11%) | 2 (6%) | 1 (3%) | 0 (0%) | 7 (19%) |
| Cognitive Impairment | 2 (6%) | 4 (11%) | 0 (0%) | 1 (3%) | 7 (19%) |
| Hypertension | 1 (3%) | 2 (6%) | 4 (11%) | 0 (0%) | 7 (19%) |
| Mucositis | 4 (11%) | 2 (6%) | 1 (3%) | 0 (0%) | 7 (19%) |
| Cough | 4 (11%) | 2 (6%) | 0 (0%) | 0 (0%) | 6 (17%) |
| Dizziness/Lightheaded | 5 (14%) | 1 (3%) | 0 (0%) | 0 (0%) | 6 (17%) |
| Dry Skin | 6 (17%) | 0 (0%) | 0 (0%) | 0 (0%) | 6 (17%) |
| Myalgia | 4 (11%) | 2 (6%) | 0 (0%) | 0 (0%) | 6 (17%) |
| Arthralgia | 3 (8%) | 1 (3%) | 0 (0%) | 0 (0%) | 4 (11%) |
| CMV Reactivation | 3 (8%) | 1 (3%) | 0 (0%) | 0 (0%) | 4 (11%) |
| Headache | 2 (6%) | 1 (3%) | 1 (3%) | 0 (0%) | 4 (11%) |
Abbreviations: ALT, alanine aminotransferase; AST, aspartate aminotransferase; CMV, cytomegalovirus; GERD, gastroesophageal reflux disease.