Table 2.
All-grade AEs with a frequency of >10% in the AML dose-escalation study (safety analysis set)
| MedDRA preferred term | AZD1208 120 mg n = 4 | AZD1208 240 mg n = 6 | AZD1208 480 mg n = 6 | AZD1208 700 mg n = 7 | AZD1208 900 mg n = 9 | Total N = 32 |
|---|---|---|---|---|---|---|
| Patients with any AE | 3 (75.0) | 6 (100.0) | 6 (100.0) | 7 (100.0) | 9 (100.0) | 31 (96.9) |
| Gastrointestinal | ||||||
| Nausea | 3 (75.0) | 4 (66.7) | 1 (16.7) | 5 (71.4) | 2 (22.2) | 15 (46.9) |
| Diarrhoea | 1 (25.0) | 1 (16.7) | 3 (50.0) | 5 (71.4) | 4 (44.4) | 14 (43.8) |
| Vomiting | 2 (50.0) | 3 (50.0) | 2 (33.3) | 2 (28.6) | 1 (11.1) | 10 (31.3) |
| Abdominal pain | 1 (25.0) | 0 | 1 (16.7) | 3 (42.9) | 1 (11.1) | 6 (18.8) |
| Stomatitis | 1 (25.0) | 1 (16.7) | 3 (50.0) | 0 | 0 | 5 (15.6) |
| Decreased appetite | 0 | 1 (16.7) | 0 | 2 (28.6) | 1 (11.1) | 4 (12.5) |
| General disorders | ||||||
| Fatigue | 1 (25.0) | 1 (16.7) | 4 (66.7) | 2 (28.6) | 2 (22.2) | 10 (31.3) |
| Oedema peripheral | 1 (25.0) | 1 (16.7) | 3 (50.0) | 2 (28.6) | 2 (22.2) | 9 (28.1) |
| Asthenia | 1 (25.0) | 0 | 1 (16.7) | 1 (14.3) | 2 (22.2) | 5 (15.6) |
| Chills | 0 | 1 (16.7) | 0 | 1 (14.3) | 2 (22.2) | 4 (12.5) |
| Pyrexia | 0 | 0 | 1 (16.7) | 0 | 3 (33.3) | 4 (12.5) |
| Vascular disorders | ||||||
| Hypotension | 1 (25.0) | 2 (33.3) | 2 (33.3) | 3 (42.9) | 2 (22.2) | 10 (31.3) |
| Blood and lymphatic system disorders | ||||||
| Febrile neutropenia | 3 (75.0) | 2 (33.3) | 0 | 1 (14.3) | 3 (33.3) | 9 (28.1) |
| Respiratory disorders | ||||||
| Cough | 0 | 1 (16.7) | 1 (16.7) | 4 (57.1) | 2 (22.2) | 8 (25.0) |
| Dyspnoea | 0 | 1 (16.7) | 2 (33.3) | 2 (28.6) | 2 (22.2) | 7 (21.9) |
| Metabolic and nutritional disorders | ||||||
| Hypocalcaemia | 1 (25.0) | 1 (16.7) | 1 (16.7) | 3 (42.9) | 1 (11.1) | 7 (21.9) |
| Hypokalaemia | 0 | 0 | 3 (50.0) | 2 (28.6) | 2 (22.2) | 7 (21.9) |
| Hypomagnesaemia | 1 (25.0) | 1 (16.7) | 2 (33.3) | 2 (28.6) | 1 (11.1) | 7 (21.9) |
| Hypophosphataemia | 1 (25.0) | 0 | 2 (33.3) | 1 (14.3) | 2 (22.2) | 6 (18.8) |
| Hyperglycaemia | 0 | 0 | 2 (33.3) | 1 (14.3) | 2 (22.2) | 5 (15.6) |
| Dehydration | 0 | 0 | 0 | 0 | 4 (44.4) | 4 (12.5) |
| Infections and infestations | ||||||
| Pneumonia | 1 (25.0) | 3 (50.0) | 2 (33.3) | 0 | 0 | 6 (18.8) |
| Nervous system disorders | ||||||
| Headache | 0 | 0 | 3 (50.0) | 1 (14.3) | 0 | 4 (12.5) |
| Skin and subcutaneous disorders | ||||||
| Rash | 0 | 0 | 1 (16.7) | 1 (14.3) | 2 (22.2) | 4 (12.5) |
| Maculopapular rash | 0 | 1 (16.7) | 0 | 2 (28.6) | 1 (11.1) | 4 (12.5) |
| Renal and urinary disorders | ||||||
| Renal failure acute | 0 | 1 (16.7) | 2 (33.3) | 1 (14.3) | 0 | 4 (12.5) |
| Eye disorders | ||||||
| Vision blurred | 1 (25.0) | 0 | 3 (50.0) | 0 | 0 | 4 (12.5) |
Data are n (%) patients with AEs, sorted in decreasing frequency of preferred term (sorted by total column even when not reported). The number of evaluable patients in each dose cohort was: 120 mg, n = 3; 240 mg, n = 3; 480 mg, n = 3; 700 mg, n = 4; 900 mg, n = 3. Data include AEs with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of study medication. MedDRA version 17.0. was used.
AE adverse event, AML acute myeloid leukaemia, MedDRA Medical Dictionary for Regulatory Activities