Table 2.
Treatment-related toxicities in the phase II study of RO4929097 with or without vismodegib occurring in ≥ 5% of patients. Values represent number of patients (%) experiencing each toxicity.
| RO4929097 (n = 33) | RO4929097 plus vismodegib (n = 33) | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Toxicity | Grade 1 | Grade 2 | Grade 3 | Grade 4 | Grade 1 | Grade 2 | Grade 3 | Grade 4 | Total |
| Alanine aminotransferase increased | 4 (12%) | 1 (3%) | 2 (6%) | 0 (0%) | 11 (33%) | 3 (9%) | 0 (0%) | 0 (0%) | 21 (31%) |
| Nausea | 8 (24%) | 2 (6%) | 0 (0%) | 0 (0%) | 7 (21%) | 3 (9%) | 0 (0%) | 0 (0%) | 20 (30%) |
| Hypophosphatemia | 1 (3%) | 7 (21%) | 5 (15%) | 0 (0%) | 0 (0%) | 6 (18%) | 1 (3%) | 0 (0%) | 20 (30%) |
| Fatigue | 8 (24%) | 2 (6%) | 0 (0%) | 0 (0%) | 6 (18%) | 2 (6%) | 0 (0%) | 0 (0%) | 18 (27%) |
| Hyperglycemia | 6 (18%) | 2 (6%) | 0 (0%) | 0 (0%) | 7 (21%) | 0 (0%) | 0 (0%) | 0 (0%) | 15 (22%) |
| Hypoalbuminemia | 4 (12%) | 0 (0%) | 0 (0%) | 0 (0%) | 7 (21%) | 2 (6%) | 0 (0%) | 0 (0%) | 13 (19%) |
| White blood cells decreased | 2 (6%) | 3 (9%) | 0 (0%) | 0 (0%) | 5 (15%) | 2 (6%) | 1 (3%) | 0 (0%) | 13 (19%) |
| Hyponatremia | 3 (9%) | 0 (0%) | 0 (0%) | 0 (0%) | 8 (24%) | 0 (0%) | 1 (3%) | 0 (0%) | 12 (18%) |
| Alkaline phosphatase increased | 4 (12%) | 1 (3%) | 1 (3%) | 0 (0%) | 6 (18%) | 0 (0%) | 0 (0%) | 0 (0%) | 12 (18%) |
| Aspartate aminotransferase increased | 1 (3%) | 1 (3%) | 1 (3%) | 0 (0%) | 6 (18%) | 0 (0%) | 0 (0%) | 0 (0%) | 9 (13%) |
| Musculoskeletal and connective tissue disorders | 3 (9%) | 1 (3%) | 0 (0%) | 0 (0%) | 3 (9%) | 2 (6%) | 0 (0%) | 0 (0%) | 9 (13%) |
| Anemia | 1 (3%) | 0 (0%) | 0 (0%) | 0 (0%) | 6 (18%) | 0 (0%) | 1 (3%) | 0 (0%) | 8 (12%) |
| Dysgeusia | 5 (15%) | 0 (0%) | 0 (0%) | 0 (0%) | 1 (3%) | 2 (6%) | 0 (0%) | 0 (0%) | 8 (12%) |
| Constipation | 3 (9%) | 1 (3%) | 0 (0%) | 0 (0%) | 2 (6%) | 1 (3%) | 0 (0%) | 0 (0%) | 7 (10%) |
| Neutrophil count decreased | 0 (0%) | 4 (12%) | 0 (0%) | 1 (3%) | 0 (0%) | 1 (3%) | 1 (3%) | 0 (0%) | 7 (10%) |
| Vomiting | 5 (15%) | 1 (3%) | 0 (0%) | 0 (0%) | 1 (3%) | 0 (0%) | 0 (0%) | 0 (0%) | 7 (10%) |
| Platelet count decreased | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 5 (15%) | 0 (0%) | 0 (0%) | 0 (0%) | 5 (7%) |
| Lymphocyte count decreased | 0 (0%) | 0 (0%) | 1 (3%) | 0 (0%) | 2 (6%) | 0 (0%) | 2 (6%) | 0 (0%) | 5 (7%) |
| Anorexia | 2 (6%) | 0 (0%) | 0 (0%) | 0 (0%) | 2 (6%) | 1 (3%) | 0 (0%) | 0 (0%) | 5 (7%) |
| Myalgia | 2 (6%) | 0 (0%) | 0 (0%) | 0 (0%) | 3 (9%) | 0 (0%) | 0 (0%) | 0 (0%) | 5 (7%) |
| Skin and subcutaneous tissue disorders | 2 (6%) | 0 (0%) | 0 (0%) | 0 (0%) | 3 (9%) | 0 (0%) | 0 (0%) | 0 (0%) | 5 (7%) |
| Creatine phosphokinase increased | 1 (3%) | 2 (6%) | 0 (0%) | 0 (0%) | 2 (6%) | 0 (0%) | 0 (0%) | 0 (0%) | 5 (7%) |
| Alopecia | 2 (6%) | 2 (6%) | 0 (0%) | 0 (0%) | 1 (3%) | 0 (0%) | 0 (0%) | 0 (0%) | 5 (7%) |
| Oral mucositis | 4 (12%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 4 (6%) |