Table 2. Adverse Events Reported in ≥20% of Patients Regardless of Causalitya.
| Adverse Event | No. (%) | |||||
|---|---|---|---|---|---|---|
| 300 mg Once Daily (n = 9) | 350 mg Once Daily (n = 8) | 400 mg Once Daily (n = 70) | ||||
| All-Grade | Grade 3/4 | All-Grade | Grade 3/4 | All-Grade | Grade 3/4 | |
| Nausea | 5 (56) | 0 | 6 (75) | 0 | 35 (50) | 0 |
| Diarrhea | 5 (56) | 0 | 6 (75) | 1 (13) | 41 (59) | 3 (4) |
| Hyperglycemia | 4 (44) | 1 (11) | 5 (63) | 2 (25) | 34 (49) | 16 (23) |
| Fatigue | 4 (44) | 0 | 7 (88) | 0 | 25 (36) | 3 (4) |
| Dysgeusia | 4 (44) | 0 | 1 (13) | 0 | 14 (20) | 0 |
| Vomiting | 3 (33) | 0 | 4 (50) | 0 | 23 (33) | 2 (3) |
| Stomatitis | 3 (33) | 0 | 3 (38) | 0 | 19 (27) | 1 (1) |
| Headache | 3 (33) | 0 | 3 (38) | 0 | 11 (16) | 0 |
| Rash | 3 (33) | 0 | 4 (50) | 1 (13) | 10 (14) | 6 (9) |
| Dizziness | 3 (33) | 0 | 2 (25) | 0 | 6 (9) | 0 |
| Decreased appetite | 2 (22) | 0 | 4 (50) | 0 | 33 (47) | 1 (1) |
| Arthralgia | 2 (22) | 0 | 2 (25) | 0 | 13 (19) | 0 |
| Increased AST | 2 (22) | 0 | 2 (25) | 0 | 11 (16) | 5 (7) |
| Anemia | 2 (22) | 0 | 1 (13) | 0 | 13 (19) | 2 (3) |
| Constipation | 2 (22) | 0 | 1 (13) | 0 | 10 (14) | 0 |
| Amylase level increased | 2 (22) | 0 | 0 | 0 | 1 (1) | 0 |
| Rhinorrhea | 2 (22) | 0 | 0 | 0 | 1 (1) | 0 |
| Muscle spasms | 1 (11) | 0 | 5 (63) | 0 | 7 (10) | 0 |
| Upper respiratory tract infection | 1 (11) | 0 | 3 (38) | 0 | 10 (14) | 0 |
| Pruritus | 1 (11) | 0 | 3 (38) | 0 | 10 (14) | 2 (3) |
| Asthenia | 1 (11) | 0 | 3 (38) | 0 | 7 (10) | 0 |
| Dry skin | 1 (11) | 0 | 2 (25) | 0 | 13 (19) | 0 |
| Alopecia | 1 (11) | 0 | 2 (25) | 0 | 11 (16) | 0 |
| Dry mouth | 1 (11) | 0 | 2 (25) | 0 | 6 (9) | 0 |
| Hypomagnesemia | 1 (11) | 0 | 2 (25) | 0 | 3 (4) | 0 |
| Abdominal pain | 0 | 0 | 4 (50) | 0 | 9 (13) | 1 (1) |
| Weight decreased | 0 | 0 | 3 (38) | 0 | 11 (16) | 0 |
| Pyrexia | 0 | 0 | 3 (38) | 0 | 9 (13) | 0 |
| Thirst | 0 | 0 | 3 (38) | 0 | 0 | 0 |
| Musculoskeletal pain | 0 | 0 | 2 (25) | 0 | 8 (11) | 0 |
| Dehydration | 0 | 0 | 2 (25) | 0 | 5 (7) | 1 (1) |
| Dyspepsia | 0 | 0 | 2 (25) | 0 | 2 (3) | 0 |
| Erythema | 0 | 0 | 2 (25) | 0 | 3 (4) | 0 |
| Flushing | 0 | 0 | 2 (25) | 0 | 1 (1) | 0 |
| Cough | 0 | 0 | 1 (13) | 0 | 17 (24) | 0 |
| Rash (maculopapular) | 0 | 0 | 2 (25) | 2 (25) | 17 (24) | 9 (13) |
Abbreviation: AST, aspartate aminotransferase.
a
There were 5 deaths during treatment, all in patients receiving alpelisib, 400 mg, once daily plus fulvestrant. None of the during-treatment deaths were suspected as study treatment related.