Table 3.
Treatment-emergent AEs occurring in three or more patients irrespective of causality
| Number of patients experiencing AE | Study 1 AZD5438 dose (mg, q.i.d.) |
Study 2 AZD5438 dose (mg, q.i.d.) |
Study 3 AZD5438 dose (mg, q.i.d.) |
||||||||||||||
| 10 (3) | 20 (3) | 40 (4) | 60 (6) | 90 (3) | Total n (%) (19) | 5 (3) | 10 (3) | 20 (3) | 40 (8) | Total n (%) (17) | 2.5 (3) | 5(3) | 10 (5) | 20 (11) | 40 (6) | Total n (%) (28) | |
| Nausea | 1 | 3 | 3a | 4 | 2 | 13 (68) | 1 | 2 | 3 | 7a | 13 (76) | 1 | 1 | 3 | 5 | 4 | 14 (50) |
| Vomiting | 0 | 1 | 3a | 4 | 3 | 11 (58) | 1 | 0 | 2 | 4 | 7 (41) | 1 | 0 | 4 | 4a | 3 | 12 (43) |
| Diarrhoea | 1 | 1 | 0 | 4a | 1 | 7 (37) | 0 | 0 | 1 | 3 | 4 (24) | 1 | 0 | 0 | 1 | 2 | 4 (14) |
| Constipation | 2 | 1 | 2a | 1 | 0 | 6 (32) | 0 | 1 | 1 | 3 | 5 (29) | 1 | 0 | 2 | 3 | 0 | 6 (21) |
| Abdominal pain | 0 | 0 | 0 | 2 | 1 | 3 (16) | 0 | 0 | 0 | 3 | 3 (18) | ||||||
| Fatigue | 1 | 1 | 1 | 1 | 2a | 6 (32) | 1 | 1 | 1 | 5 | 8 (47) | 1 | 2 | 2 | 5 | 5a | 15 (54) |
| Pyrexia | 0 | 2 | 0 | 3 | 0 | 5 (26) | 0 | 0 | 0 | 3 | 3 (18) | 0 | 0 | 1 | 1 | 2 | 4 (14) |
| Nasopharyngitis | 1 | 1 | 1 | 0 | 1 | 4 (21) | |||||||||||
| Anorexia | 0 | 0 | 1 | 1 | 1 | 3 (16) | 0 | 2 | 2 | 3 | 7 (41) | 0 | 0 | 1 | 3a | 1 | 5 (18) |
| Back pain | 0 | 0 | 0 | 3a | 0 | 3 (16) | 1 | 0 | 1 | 1 | 3 (18) | ||||||
| Headache | 1 | 0 | 2 | 0 | 2 | 5 (26) | 1 | 0 | 1 | 1 | 3 (18) | 0 | 0 | 1 | 2 | 1 | 4 (14) |
| Urinary retention | 0 | 0 | 1 | 2 | 0 | 3 (16) | |||||||||||
| Dyspnoea | 1 | 0 | 0 | 1a | 1b | 3 (16) | 0 | 0 | 1a | 2 | 2 | 5 (18) | |||||
| Lethargy | 1 | 1 | 2 | 1 | 5 (29) | ||||||||||||
| Cough | 1 | 0 | 0 | 3 | 4 (24) | 1 | 0 | 1 | 1 | 0 | 3 (11) | ||||||
| Dyspepsia | 1 | 0 | 1 | 1 | 3 (18) | ||||||||||||
| Dehydration | 0 | 0 | 0 | 2 | 1 | 3 (11) | |||||||||||
| Dizziness | 0 | 1 | 0 | 2 | 0 | 3 (11) | |||||||||||
| Oedema | 0 | 1 | 0 | 1a | 1 | 3 (11) | |||||||||||
a
All AEs were CTC grade 1 or 2 except for CTC grade 3 AEs (n = 1).
b
All AEs were CTC grade 1 or 2 except for a single CTC grade 4 AE.
AE, adverse event.