TABLE A2.
Safety Summary (safety-evaluable population)
| Patients | Inavo + Palbo + Letro Arm (n = 33), No. (%) | Inavo + Palbo + Fulv Arm (n = 20), No. (%) |
|---|---|---|
| Patients with at least one AE | 33 (100) | 20 (100) |
| Related to any study treatment | 33 (100) | 20 (100) |
| Related to Inavo | 33 (100) | 20 (100) |
| Patients with at least one grade 3-4 AE | 30 (90.9) | 17 (85.0) |
| Related to any study treatment | 29 (87.9) | 17 (85.0) |
| Related to Inavo | 19 (57.6) | 6 (30.0) |
| Patients with at least one serious AE | 14 (42.4) | 6 (30.0) |
| Related to any study treatment | 5 (15.2) | 0 |
| Related to Inavo | 4 (12.1)a | 0 |
| AE leading to dose modification (interruption, reduction, or withdrawal) of any treatment | 31 (93.9) | 20 (100) |
| AE leading to discontinuation of any treatment | 2 (6.1) | 2 (10.0) |
| Deaths | 0 | 0 |
Abbreviations: AE, adverse event; Fulv, fulvestrant; Inavo, inavolisib; Letro, letrozole; Palbo, palbociclib.
a
Grade 3 cellulitis, grade 3 wound cellulitis, grade 2 confusional state, and grade 2 osteomyelitis.