Table 2.
Summary of AEs occurring in ≥20% of all patients, AEs of grade ≥3 occurring in ≥5% of all patients, and SAEs for each cohort
AZD4547 dose | ||||||
---|---|---|---|---|---|---|
Part A | Part B | |||||
40 mg bid (N = 3) |
80 mg bid (N = 6) | 120 mg bid (N = 6) | 160 mg qd (N = 15) |
Total Part A (N = 30) |
80 mg bid (N = 4) |
|
Patients with AE of any grade, n (%) | 3 (100) | 6 (100) | 6 (100) | 14 (93.3) | 29 (97.6) | 4 (100) |
Dysgeusia | 0 (0) | 2 (33.3) | 5 (83.3) | 7 (50.0) | 14 (46.7) | 3 (75.0) |
Diarrhoea | 0 (0) | 2 (33.3) | 5 (83.3) | 5 (33.3) | 12 (40.0) | 1 (25.0) |
Stomatitis | 1 (33.3) | 4 (66.7) | 4 (66.7) | 3 (20.0) | 12 (40.0) | 2 (50.0) |
Hyperphosphataemia | 0 (0) | 1 (16.7) | 3 (50.0) | 7 (50.0) | 11 (36.7) | 2 (50.0) |
Dry mouth | 0 (0) | 3 (50.0) | 2 (33.3) | 5 (33.3) | 10 (33.3) | 2 (50.0) |
Dry skin | 1 (33.3) | 2 (33.3) | 2 (33.3) | 4 (26.7) | 9 (30.0) | 0 (0) |
Nausea | 1 (33.3) | 2 (33.3) | 1 (16.7) | 4 (26.7) | 8 (26.7) | 2 (50.0) |
Detachment of retinal pigment epithelium | 0 (0) | 0 (0) | 0 (0) | 7 (50.0) | 7 (23.3) | 1 (25.0) |
Vomiting | 0 (0) | 2 (33.3) | 2 (33.3) | 2 (13.3) | 6 (20.0) | 1 (25.0) |
Malaise | 0 (0) | 2 (33.3) | 2 (33.3) | 2 (13.3) | 6 (20.0) | 1 (25.0) |
Decreased appetite | 1 (33.3) | 1 (16.7) | 1 (16.7) | 2 (13.3) | 6 (20.0) | 2 (50.0) |
Patients with CTCAE grade ≥3 event, n (%) | 0 (0) | 3 (50.0) | 0 (0) | 0 (0) | 3 (10.0) | 3 (75.0) |
Neutropenia | 0 (0) | 2 (33.3) | 0 (0) | 0 (0) | 2 (6.7) | 1 (25.0) |
Nausea | 0 (0) | 2 (33.3) | 0 (0) | 0 (0) | 2 (6.7) | 0 (0) |
Decreased appetite | 0 (0) | 1 (16.7) | 0 (0) | 0 (0) | 1 (3.3) | 2 (50.0) |
Stomatitis | 0 (0) | 1 (16.7) | 0 (0) | 0 (0) | 1 (3.3) | 0 (0) |
Pneumonia | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 1 (3.3) | 1 (25.0) |
Increased alanine aminotransferase | 0 (0) | 1 (16.7) | 0 (0) | 0 (0) | 1 (3.3) | 0 (0) |
Decreased appetite | 0 (0) | 1 (16.7) | 0 (0) | 0 (0) | 1 (3.3) | 0 (0) |
Hypoglycaemia | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 1 (3.3) | 1 (25.0) |
Patients with SAE grade ≥3 event, n (%) | 0 (0) | 0 (0) | 2 (33.3) | 0 (0) | 2 (6.7) | 1 (25.0) |
Nausea | 0 (0) | 0 (0) | 1 (16.7) | 0 (0) | 1 (3.3) | 0 (0) |
Stomatitis | 0 (0) | 0 (0) | 1 (16.7) | 0 (0) | 1 (3.3) | 0 (0) |
Decreased appetite | 0 (0) | 0 (0) | 1 (16.7) | 0 (0) | 1 (3.3) | 1 (25.0) |
SAE serious adverse event