Table 2.
Summary of adverse events: number (%) of patients reporting at least one adverse event (frequency >35 %)
| Continuous | Intermittent | |||||||
|---|---|---|---|---|---|---|---|---|
| 80 mg bid | 240 mg bid | 320 mg bid | 400 mg bid | 360 mg bid 4/3 | 480 mg bid 4/3 | 640 mg bid 2/5 | Total | |
| n | 3 | 7 | 6 | 5 | 8 | 6 | 6 | 41 |
| Adverse events (AEs) | ||||||||
| Any | 3 (100.0) | 6 (85.7) | 6 (100.0) | 5 (100.0) | 8 (100.0) | 6 (100.0) | 6 (100.0) | 40 (97.6) |
| Diarrhea | 0 (0.0) | 5 (71.4) | 5 (83.3) | 5 (100.0) | 7 (87.5) | 5 (83.3) | 5 (83.3) | 32 (78.0) |
| Hyperglycemia | 0 (0.0) | 3 (42.9) | 4 (66.7) | 5 (100.0) | 5 (62.5) | 5 (83.3) | 6 (100.0) | 28 (68.3) |
| Nausea | 1 (33.3) | 3 (42.9) | 5 (83.3) | 5 (100.0) | 3 (37.5) | 3 (50.0) | 3 (50.0) | 23 (56.1) |
| Maculopapular rash | 0 (0.0) | 2 (28.6) | 4 (66.7) | 5 (100.0) | 3 (37.5) | 6 (100.0) | 3 (50.0) | 23 (56.1) |
| Decreased appetite | 0 (0.0) | 2 (28.6) | 4 (66.7) | 4 (80.0) | 5 (62.5) | 2 (33.3) | 3 (50.0) | 20 (48.8) |
| Pyrexia | 1 (33.3) | 4 (57.1) | 3 (50.0) | 5 (100.0) | 3 (37.5) | 3 (50.0) | 1 (16.7) | 20 (48.8) |
| Stomatitis | 0 (0.0) | 3 (42.9) | 3 (50.0) | 4 (80.0) | 3 (37.5) | 3 (50.0) | 1 (16.7) | 17 (41.5) |
| Proteinuria | 0 (0.0) | 0 (0.0) | 3 (50.0) | 1 (20.0) | 3 (37.5) | 4 (66.7) | 5 (83.3) | 16 (39.0) |
| Blood creatinine increased | 0 (0.0) | 2 (28.6) | 4 (66.7) | 3 (60.0) | 2 (25.0) | 2 (33.3) | 1 (16.7) | 14 (34.1) |
| White blood cell count decreased | 0 (0.0) | 1 (14.3) | 3 (50.0) | 1 (20.0) | 3 (37.5) | 4 (66.7) | 1 (16.7) | 13 (31.7) |
| AEs causally related to AZD5363a | ||||||||
| Any | 3 (100.0) | 6 (85.7) | 6 (100.0) | 5 (100.0) | 7 (87.5) | 6 (100.0) | 6 (100.0) | 39 (95.1) |
| AEs of CTCAE grade ≥3 | ||||||||
| Any | 0 (0.0) | 3 (42.9) | 4 (66.7) | 5 (100.0) | 5 (62.5) | 4 (66.7) | 5 (83.3) | 26 (63.4) |
| Hyperglycemia | 0 (0.0) | 2 (28.6) | 2 (33.3) | 3 (60.0) | 1 (12.5) | 3 (50.0) | 5 (83.3) | 16 (39.0) |
| Diarrhea | 0 (0.0) | 0 (0.0) | 3 (50.0) | 1 (20.0) | 2 (25.0) | 0 (0.0) | 1 (16.7) | 7 (17.1) |
| Neutrophil count decreased | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 3 (37.5) | 0 (0.0) | 1 (16.7) | 4 (9.8) |
| Lymphocyte count decreased | 0 (0.0) | 1 (14.3) | 1 (16.7) | 1 (20.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 3 (7.3) |
| AEs of CTCAE grade ≥3 causally related to AZD5363a | ||||||||
| Any | 0 (0.0) | 3 (42.9) | 4 (66.7) | 5 (100.0) | 3 (37.5) | 4 (66.7) | 5 (83.3) | 24 (58.5) |
| AE with outcome of death | ||||||||
| Any | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| SAE | ||||||||
| Any | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (16.7) | 2 (33.3) | 3 (7.3) |
| SAE causally related to AZD5363a | ||||||||
| Any | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| AEs leading to discontinuation of AZD5363 | ||||||||
| Any | 0 (0.0) | 1 (14.3) | 1 (16.7) | 1 (20.0) | 0 (0.0) | 1 (16.7) | 1 (16.7) | 5 (12.2) |
aAs assessed by the investigator