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. 2017 Jan 10;35(4):451–462. doi: 10.1007/s10637-016-0416-x

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