Table 3.
Safety Summary
| Telaglenastat + Everolimus (n=46) |
Placebo + Everolimus (n=23) |
|
|---|---|---|
| n (%) | ||
| All Grade TEAEs | 46 (100) | 23 (100) |
| Grade 3–4 TEAEs | 34 (74) | 14 (61) |
| Grade 5 TEAEsa | 2 (4) | 1 (4) |
| TEAE leading to treatment discontinuation | ||
| Everolimus | 12 (26) | 8 (35) |
| Telaglenastat or placebo | 12 (26) | 8 (35) |
| TEAE leading to dose reduction | ||
| Everolimus | 26 (57) | 6 (26) |
| Telaglenastat or placebo | 11 (24) | 3 (13) |
| TEAE leading to dose interruption or reduction | ||
| Everolimus | 36 (78) | 15 (65) |
| Telaglenastat or placebo | 34 (74) | 15 (65) |
TEAE, treatment-emergent adverse event.
z
In the telaglenastat-everolimus group, 1 patient died from cardio-respiratory arrest and 1 patient died from respiratory distress. In the placebo-everolimus group, 1 patient died from cardio-respiratory arrest. None of these deaths were deemed related to telaglenastat, placebo, or everolimus.