Table 4.
All-grade AEs with a frequency of >10% in the solid tumour dose-escalation study (safety analysis set)
| MedDRA preferred term | AZD1208 120 mg n = 3 | AZD1208 240 mg n = 7 | AZD1208 360 mg n = 6 | AZD1208 540 mg n = 7 | AZD1208 700 mg n = 6 | AZD1208 800 mg n = 6 | Total N = 35 |
|---|---|---|---|---|---|---|---|
| Patients with any AE | 3 (100.0) | 7 (100.0) | 6 (100.0) | 7 (100.0) | 6 (100.0) | 6 (100.0) | 35 (100.0) |
| Gastrointestinal disorders | |||||||
| Diarrhoea | 2 (66.7) | 5 (71.4) | 5 (83.3) | 6 (85.7) | 5 (83.3) | 6 (100.0) | 29 (82.9) |
| Nausea | 1 (33.3) | 6 (85.7) | 3 (50.0) | 7 (100.0) | 5 (83.3) | 4 (66.7) | 26 (74.3) |
| Vomiting | 0 (0.0) | 6 (85.7) | 1 (16.7) | 5 (71.4) | 4 (66.7) | 3 (50.0) | 19 (54.3) |
| Abdominal pain | 0 (0.0) | 3 (42.9) | 2 (33.3) | 2 (28.6) | 1 (16.7) | 0 (0.0) | 8 (22.9) |
| Constipation | 0 (0.0) | 0 (0.0) | 3 (50.0) | 0 (0.0) | 2 (33.3) | 0 (0.0) | 5 (14.3) |
| Blood and lymphatic system disorders | |||||||
| Anaemia | 3 (100.0) | 4 (57.1) | 2 (33.3) | 4 (57.1) | 3 (50.0) | 2 (33.3) | 18 (51.4) |
| Thrombocytopenia | 0 (0.0) | 0 (0.0) | 2 (33.3) | 1 (14.3) | 1 (16.7) | 1 (16.7) | 5 (14.3) |
| General disorders | |||||||
| Fatigue | 0 (0.0) | 2 (28.6) | 3 (50.0) | 3 (42.9) | 4 (66.7) | 5 (83.3) | 17 (48.6) |
| Pyrexia | 0 (0.0) | 1 (14.3) | 3 (50.0) | 0 (0.0) | 2 (33.3) | 0 (0.0) | 6 (17.1) |
| Metabolic and nutritional disorders | |||||||
| Decreased appetite | 1 (33.3) | 3 (42.9) | 2 (33.3) | 4 (57.1) | 2 (33.3) | 3 (50.0) | 15 (42.9) |
| Hypoalbuminaemia | 1 (33.3) | 2 (28.6) | 2 (33.3) | 1 (14.3) | 3 (50.0) | 0 (0.0) | 9 (25.7) |
| Hyperglycaemia | 1 (33.3) | 0 (0.0) | 1 (16.7) | 4 (57.1) | 0 (0.0) | 2 (33.3) | 8 (22.9) |
| Hyponatraemia | 0 (0.0) | 0 (0.0) | 1 (16.7) | 3 (42.9) | 1 (16.7) | 0 (0.0) | 5 (14.3) |
| Hypokalaemia | 0 (0.0) | 0 (0.0) | 0 (0.0) | 2 (28.6) | 1 (16.7) | 1 (16.7) | 4 (11.4) |
| Investigationsa | |||||||
| Platelet count decreased | 2 (66.7) | 2 (28.6) | 1 (16.7) | 2 (28.6) | 1 (16.7) | 1 (16.7) | 9 (25.7) |
| White blood cell count decreased | 2 (66.7) | 3 (42.9) | 1 (16.7) | 2 (28.6) | 1 (16.7) | 0 (0.0) | 9 (25.7) |
| GGT increased | 0 (0.0) | 2 (28.6) | 1 (16.7) | 2 (28.6) | 0 (0.0) | 1 (16.7) | 6 (17.1) |
| Skin and subcutaneous tissue disorders | |||||||
| Dry skin | 0 (0.0) | 3 (42.9) | 1 (16.7) | 2 (28.6) | 1 (16.7) | 0 (0.0) | 7 (20.0) |
| Respiratory, thoracic and mediastinal disorders | |||||||
| Dyspnoea | 0 (0.0) | 1 (14.3) | 2 (33.3) | 1 (14.3) | 0 (0.0) | 0 (0.0) | 4 (11.4) |
| Psychiatric disorders | |||||||
| Insomnia | 0 (0.0) | 1 (14.3) | 1 (16.7) | 1 (14.3) | 0 (0.0) | 1 (16.7) | 4 (11.4) |
| Musculoskeletal and connective tissue disorders | |||||||
| Musculoskeletal chest pain | 0 (0.0) | 0 (0.0) | 2 (33.3) | 1 (14.3) | 1 (16.7) | 0 (0.0) | 4 (11.4) |
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 = 5; 360 mg, n = 2; 540 mg, n = 5; 700 mg, n = 3; 800 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, CTCAE Common Terminology Criteria for Adverse Events, GGT gamma-glutamyltransferase, MedDRA Medical Dictionary for Regulatory Activities.
aBlood cell count decreases according to CTCAE version 4.0