Table 2.
Safety Endpoints
| Number of Patients With at Least | Arm ATMZ + vismodegib, N = 10 | Arm BTMZ, N = 5 | Arm CVismodegib, N = 9 |
|---|---|---|---|
| 1 AE related to vismodegib | 9 | 4a | 9 |
| 1 grade ≥3 AE related to vismodegib | 2 | 2a | 4 |
| 1 SAE related to vismodegib as per sponsor assessment | 2 | 0 | 3 |
| Main AE related to vismodegib (>20%) per patient | |||
| Alopecia | 3 (33.3%) | 0 | 4 (44.4%) |
| Fatigue | 3 (30%) | 0 | 3 (33.3%) |
| Cramps | 4 (40%) | 1 (20%) | 3 (33.3%) |
| Diarrhea | 1 (10%) | 0 | 2 (22.2%) |
| Dysgeusia | 2 (20%) | 0 | 3 (33.3%) |
| Hemoglobin decreased | 1 (10%) | 3 (60%) | 3 (33.3%) |
| Hematological disorders | 4 (40%) | 3 (60%) | 5 (55.6%) |
| Ionogram abnormalities | 0 | 1 (20%) | 3 (33.3%) |
| Hot flush | 0 | 0 | 2 (22.2%) |
| Liver lab abnormality | 6 (60%) | 2 (40%) | 3 (33.3%) |
Abbreviations: AE, adverse events; SAE, serious adverse events; TMZ, temozolomide.
aIncluding AE post-switch to vismodegib for arm B.
AE were classified as follows: (“Fatigue,” “Asthenia”) = ‘Fatigue’; (“Cramps,” “Leg cramps,” “Muscle cramps”) = ‘Cramps’; creatinine increased, ALT (SGPT) increased, AST (SGOT) increased, alkaline phosphatase increased, GGT increased = ‘Liver lab value abnormality’; (“Leucocytes decreased,” “Leucocytes increased,” “Lymphocytes decreased,” “Neutrophils decreased,” “Neutrophils increased,” “Platelets decreased”) = ‘Hematological disorders’; (“Phosphorus decreased,” “Calcium decreased,” “Magnesium increased”) = ‘Ionogram abnormalities.’