Table 3.
AEs observed in Part A occurring in ≥ 2 patients in either of the first 2 weeks or of grade ≥ 3 severity (safety population)
| Number of patients (%) | Tablet (N = 18) Days 1–7 |
Capsule (N = 18) Days 8–14 |
Capsule (N = 18) Day 15 onwarda |
|||
|---|---|---|---|---|---|---|
| All | Grade ≥ 3 | All | Grade ≥ 3 | All | Grade ≥ 3 | |
| Any AE (irrespective of causality) | 17 (94.4) | 8 (44.4) | 15 (83.3) | 4 (22.2) | 16 (88.9) | 7 (38.9) |
| Any AE (causally relatedb) | 17 (94.4) | 7 (38.9) | 12 (66.7) | 4 (22.2) | 14 (77.8) | 6 (33.3) |
| AE by preferred term (irrespective of causality) | ||||||
| Diarrhoea | 11 (61.1) | 1 (5.6) | 6 (33.3) | 0 | 9 (50.0) | 5 (27.8) |
| Hyperglycaemia | 7 (38.9) | 6 (33.3) | 4 (22.2) | 1 (5.6) | 2 (11.1) | 1 (5.6) |
| Nausea | 4 (22.2) | 0 | 2 (11.1) | 0 | 3 (16.7) | 0 |
| Anaemia | 1 (5.6) | 0 | 3 (16.7) | 0 | 0 | 0 |
| Pyrexia | 0 | 0 | 3 (16.7) | 0 | 0 | 0 |
| Rash maculopapular | 0 | 0 | 2 (11.1) | 2 (11.1) | 0 | 0 |
| Fatigue | 3 (16.7) | 0 | 0 | 0 | 4 (22.2) | 2 (11.1) |
| Constipation | 2 (11.1) | 0 | 0 | 0 | 1 (5.6) | 0 |
| Vomiting | 2 (11.1) | 0 | 0 | 0 | 5 (27.8) | 0 |
| Tumour pain | 1 (5.6) | 1 (5.6) | 0 | 0 | 0 | 0 |
| Blood bilirubin increased | 0 | 0 | 2 (11.1) | 0 | 0 | 0 |
| ECG QT prolonged | 0 | 0 | 2 (11.1) | 0 | 0 | 0 |
| Hypokalaemia | 1 (5.6) | 0 | 1 (5.6) | 0 | 2 (11.1) | 1 (5.6) |
| Hyponatraemia | 0 | 0 | 1 (5.6) | 1 (5.6) | 0 | 0 |
| Dyspnoea | 0 | 0 | 0 | 0 | 2 (11.1) | 1 (5.6) |
| Pulmonary embolism | 0 | 0 | 0 | 0 | 1 (5.6) | 1 (5.6) |
| Intestinal obstruction | 0 | 0 | 0 | 0 | 1 (5.6) | 1 (5.6) |
| Rash macular | 0 | 0 | 0 | 0 | 1 (5.6) | 1 (5.6) |
| Rash papular | 0 | 0 | 1 (5.6) | 1 (5.6) | 0 | 0 |
aAEs with onset from Day 15 up to 28 days after the date of the last dose of AZD5363
bAs assessed by the investigator