Table 3.
Most frequent AEs with capivasertib–fulvestrant (≥ 10% incidence in the Japan subgroup)
| Japan subgroup | Global CAPItello-291 population | |||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| AE, n, (%) | Capivasertib–fulvestrant (n = 37) | Placebo–fulvestrant (n = 41) | Capivasertib–fulvestrant (n = 355) | Placebo–fulvestrant (n = 350) | ||||||||||||||||
| Grade | Any | 1 | 2 | 3 | 4 | Any | 1 | 2 | 3 | 4 | Any | 1 | 2 | 3 | 4 | Any | 1 | 2 | 3 | 4 |
| Any AE | 37 (100) | 4 (10.8) | 13 (35.1) | 19 (51.4) | 1 (2.7) | 34 (82.9) | 15 (36.6) | 13 (31.7) | 4 (9.8) | 2 (4.9) | 343 (96.6) | 52 (14.6) | 139 (39.2) | 139 (39.2) | 9 (2.5) | 288 (82.3) | 115 (32.9) | 118 (33.7) | 44 (12.6) | 10 (2.9) |
| Diarrhea | 27 (73.0) | 19 (51.4) | 4 (10.8) | 4 (10.8) | 0 | 9 (22.0) | 6 (14.6) | 3 (7.3) | 0 | 0 | 257 (72.4) | 164 (46.2) | 60 (16.9) | 33 (9.3) | 0 | 70 (20.0) | 60 (17.1) | 9 (2.6) | 1 (0.3) | 0 |
| Rasha | 18 (48.6) | 5 (13.5) | 6 (16.2) | 7 (18.9) | 0 | 3 (7.3) | 3 (7.3) | 0 | 0 | 0 | 135 (38.0) | 57 (16.1) | 35 (9.9) | 43 (12.1) | 0 | 25 (7.1) | 19 (5.4) | 5 (1.4) | 1 (0.3) | 0 |
| Stomatitis | 11 (29.7) | 4 (10.8) | 7 (18.9) | 0 | 0 | 6 (14.6) | 4 (9.8) | 2 (4.9) | 0 | 0 | 52 (14.6) | 24 (6.8) | 21 (5.9) | 7 (2.0) | 0 | 17 (4.9) | 15 (4.3) | 2 (0.6) | 0 | 0 |
| Pyrexia | 9 (24.3) | 5 (13.5) | 4 (10.8) | 0 | 0 | 5 (12.2) | 5 (12.2) | 0 | 0 | 0 | 32 (9.0) | 19 (5.4) | 12 (3.4) | 1 (0.3) | 0 | 14 (4.0) | 12 (3.4) | 2 (0.6) | 0 | 0 |
| Vomiting | 9 (24.3) | 8 (21.6) | 1 (2.7) | 0 | 0 | 1 (2.4) | 1 (2.4) | 0 | 0 | 0 | 73 (20.6) | 54 (15.2) | 13 (3.7) | 6 (1.7) | 0 | 17 (4.9) | 10 (2.9) | 5 (1.4) | 2 (0.6) | 0 |
| Nausea | 8 (21.6) | 8 (21.6) | 0 | 0 | 0 | 5 (12.2) | 3 (7.3) | 2 (4.9) | 0 | 0 | 123 (34.6) | 85 (23.9) | 35 (9.9) | 3 (0.8) | 0 | 54 (15.4) | 42 (12.0) | 10 (2.9) | 2 (0.6) | 0 |
| Dry skin | 7 (18.9) | 4 (10.8) | 3 (8.1) | 0 | 0 | 3 (7.3) | 2 (4.9) | 1 (2.4) | 0 | 0 | 25 (7.0) | 20 (5.6) | 5 (1.4) | 0 | 0 | 15 (4.3) | 13 (3.7) | 1 (0.3) | 1 (0.3) | 0 |
| Headache | 7 (18.9) | 6 (16.2) | 1 (2.7) | 0 | 0 | 7 (17.1) | 7 (17.1) | 0 | 0 | 0 | 60 (16.9) | 47 (13.2) | 12 (3.4) | 1 (0.3) | 0 | 43 (12.3) | 33 (9.4) | 8 (2.3) | 2 (0.6) | 0 |
| Cystitis | 6 (16.2) | 0 | 6 (16.2) | 0 | 0 | 1 (2.4) | 0 | 1 (2.4) | 0 | 0 | 12 (3.4) | 3 (0.8) | 8 (2.3) | 1 (0.3) | 0 | 1 (0.3) | 0 | 1 (0.3) | 0 | 0 |
| Hyperglycemia | 6 (16.2) | 2 (5.4) | 3 (8.1) | 1 (2.7) | 0 | 2 (4.9) | 2 (4.9) | 0 | 0 | 0 | 58 (16.3) | 24 (6.8) | 26 (7.3) | 7 (2.0) | 1 (0.3) | 13 (3.7) | 8 (2.3) | 4 (1.1) | 1 (0.3) | 0 |
| Malaise | 6 (16.2) | 4 (10.8) | 2 (5.4) | 0 | 0 | 6 (14.6) | 4 (9.8) | 2 (4.9) | 0 | 0 | 10 (2.8) | 7 (2.0) | 3 (0.8) | 0 | 0 | 7 (2.0) | 5 (1.4) | 2 (0.6) | 0 | 0 |
| Insomnia | 5 (13.5) | 4 (10.8) | 1 (2.7) | 0 | 0 | 1 (2.4) | 1 (2.4) | 0 | 0 | 0 | 22 (6.2) | 15 (4.2) | 7 (2.0) | 0 | 0 | 21 (6.0) | 17 (4.9) | 4 (1.1) | 0 | 0 |
| Pruritus | 5 (13.5) | 3 (8.1) | 2 (5.4) | 0 | 0 | 4 (9.8) | 2 (4.9) | 2 (4.9) | 0 | 0 | 44 (12.4) | 32 (9.0) | 10 (2.8) | 2 (0.6) | 0 | 23 (6.6) | 19 (5.4) | 4 (1.1) | 0 | 0 |
| Back pain | 4 (10.8) | 4 (10.8) | 0 | 0 | 0 | 2 (4.9) | 2 (4.9) | 0 | 0 | 0 | 32 (9.0) | 17 (4.8) | 14 (3.9) | 1 (0.3) | 0 | 24 (6.9) | 14 (4.0) | 7 (2.0) | 3 (0.9) | 0 |
| Drug eruption | 4 (10.8) | 0 | 0 | 4 (10.8) | 0 | 0 | 0 | 0 | 0 | 0 | 4 (1.1) | 0 | 0 | 4 (1.1) | 0 | 0 | 0 | 0 | 0 | 0 |
| Dysgeusia | 4 (10.8) | 4 (10.8) | 0 | 0 | 0 | 1 (2.4) | 1 (2.4) | 0 | 0 | 0 | 21 (5.9) | 17 (4.8) | 4 (1.1) | 0 | 0 | 4 (1.1) | 4 (1.1) | 0 | 0 | 0 |
AE adverse event
aGroup term (preferred terms): rash (rash, rash macular, maculopapular rash, rash papular, rash pruritic)