Table 3.
Adverse Events in the Safety Population
| Most Common Adverse Events* | ANA Alone (n = 26) | ANA + PIC (340 mg) (n = 8) | ANA + PIC (260 mg) (n = 39) | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| G1/2 | G3 | G1/2 | G3 | G1/2 | G3 | |||||||
| No. | % | No. | % | No. | % | No. | % | No. | % | No. | % | |
| Fatigue | 6 | 23 | 1 | 4 | 7 | 88 | 0 | 6 | 26 | 0 | ||
| Rash | 0 | 0 | 2 | 25 | 3 | 38† | 3 | 8 | 1 | 3 | ||
| Diarrhea | 1 | 4 | 0 | 4 | 50 | 0 | 20 | 52 | 0 | |||
| Dysgeusia | 1 | 4 | 0 | 2 | 25 | 0 | 4 | 10 | 0 | |||
| Dyspepsia | 0 | 0 | 1 | 13 | 0 | 7 | 18 | 0 | ||||
| Anorexia | 1 | 4 | 0 | 2 | 25 | 0 | 5 | 13 | 0 | |||
| Nausea | 3 | 12 | 0 | 7 | 88 | 0 | 16 | 41 | 0 | |||
| Vomiting | 0 | 0 | 2 | 25 | 0 | 5 | 13 | 0 | ||||
| Stomatitis | 0 | 0 | 1 | 13 | 0 | 2 | 5 | 0 | ||||
| Hyperglycemia | 0 | 0 | 0 | 0 | 3 | 8 | 1 | 3 | ||||
| Creatinine | 0 | 0 | 3 | 38 | 0 | 3 | 8 | 0 | ||||
| Arthralgia | 5 | 19 | 0 | 1 | 13 | 0 | 1 | 3 | 0 | |||
| Headache | 4 | 16 | 0 | 1 | 13 | 0 | 3 | 8 | 0 | |||
| Hot flashes | 6 | 23 | 0 | 0 | 0 | 2 | 5 | 0 | ||||
NOTE. The safety population includes all patients who received at least one dose of the study drug.
Abbreviations: ANA, anastrozole; G, grade; PIC, pictilisib.
*
Included are all adverse events with an incidence of 10% or more in either group.
†
Fisher’s exact P = .013 between PIC 340 mg and 260 mg.