Table 2. All-Grade TEAEs At Least Possibly Related to AZD3965 (All Patients who Received AZD3965).
| CTCAE Body System CTCAE AE Term n (%) | All patients N=40 | ||
|---|---|---|---|
| Grade 1–2 | Grade ≥3 | All Grades | |
| All Related TEAEs | 24 (60.0) | 5 (12.5) | 29 (72.5) |
| Eye disorders | 16 (40.0) | 0 (0.0) | 16 (40.0) |
| Retinopathya | 15 (37.5) | 0 (0.0) | 15 (37.5) |
| Blurred vision | 2 (5.0) | 0 (0.0) | 2 (5.0) |
| Eye disorders – other | 1 (2.5) | 0 (0.0) | 1 (2.5) |
| Eye pain | 1 (2.5) | 0 (0.0) | 1 (2.5) |
| Metabolism and nutrition disorders | 10 (25.0) | 2 (5.0) | 12 (30.0) |
| Anorexia | 7 (17.5) | 0 (0.0) | 7 (17.5) |
| Metabolism and nutrition disorders – other | 7 (17.5) | 0 (0.0) | 7 (17.5) |
| Hypophosphataemia | 1 (2.5) | 2 (5.0) | 3 (7.5) |
| Acidosis | 0 (0.0) | 1 (2.5) | 1 (2.5) |
| Hyponatremia | 1 (2.5) | 0 (0.0) | 1 (2.5) |
| Gastrointestinal disorders | 10 (25.0) | 1 (2.5) | 11 (27.5) |
| Nausea | 7 (17.5) | 0 (0.0) | 7 (17.5) |
| Vomiting | 3 (7.5) | 1 (2.5) | 4 (10.0) |
| Mucositis oral | 2 (5.0) | 0 (0.0) | 2 (5.0) |
| Constipation | 1 (2.5) | 0 (0.0) | 1 (2.5) |
| Dry mouth | 1 (2.5) | 0 (0.0) | 1 (2.5) |
| Dyspepsia | 1 (2.5) | 0 (0.0) | 1 (2.5) |
| General disorders and administration site conditions | 8 (20.0) | 1 (2.5) | 9 (22.5) |
| Fatigue | 8 (20.0) | 1 (2.5) | 9 (22.5) |
| Malaise | 1 (2.5) | 0 (0.0) | 1 (2.5) |
| Blood and lymphatic system disorders | 3 (7.5) | 2 (5.0) | 5 (12.5) |
| Anaemia | 3 (7.5) | 2 (5.0) | 5 (12.5) |
| Nervous system disorders | 5 (12.5) | 0 (0.0) | 5 (12.5) |
| Dysgeusia | 2 (5.0) | 2 (5.0) | 2 (5.0) |
| Concentration impairment | 1 (2.5) | 0 (0.0) | 1 (2.5) |
| Headache | 1 (2.5) | 0 (0.0) | 1 (2.5) |
| Dizziness | 1 (2.5) | 0 (0.0) | 1 (2.5) |
| Investigations | 2 (5.0) | 2 (5.0) | 4 (10.0) |
| Alkaline phosphatase increased | 1 (2.5) | 0 (0.0) | 1 (2.5) |
| Cardiac troponin I increased | 0 (0.0) | 1 (2.5) | 1 (2.5) |
| Cardiac troponin T increased | 1 (2.5) | 0 (0.0) | 1 (2.5) |
| Lymphocyte count decreased | 0 (0.0) | 1 (2.5) | 1 (2.5) |
| Respiratory, thoracic and mediastinal disorders | 3 (7.5) | 1 (2.5) | 4 (10.0) |
| Dyspnoea | 1 (2.5) | 0 (0.0) | 1 (2.5) |
| Epistaxis | 1 (2.5) | 0 (0.0) | 1 (2.5) |
| Hoarseness | 1 (2.5) | 0 (0.0) | 1 (2.5) |
| Pneumonitis | 0 (0.0) | 1 (2.5) | 1 (2.5) |
| Renal and urinary disorders | 3 (7.5) | 3 (7.5) | 3 (7.5) |
| Cystitis noninfective | 1 (2.5) | 0 (0.0) | 1 (2.5) |
| Proteinuria | 1 (2.5) | 0 (0.0) | 1 (2.5) |
| Urine discolouration | 1 (2.5) | 0 (0.0) | 1 (2.5) |
| Injury, poisoning and procedural complications | 1 (2.5) | 0 (0.0) | 1 (2.5) |
| Bruising | 1 (2.5) | 0 (0.0) | 1 (2.5) |
| Musculoskeletal and connective tissue disorders | 1 (2.5) | 0 (0.0) | 1 (2.5) |
| Pain in extremity | 1 (2.5) | 0 (0.0) | 1 (2.5) |
| Neoplasms benign, malignant and unspecified | 0 (0.0) | 1 (2.5) | 1 (2.5) |
| Myelodysplastic syndrome | 0 (0.0) | 1 (2.5) | 1 (2.5) |
| Skin and subcutaneous tissue disorders | 1 (2.5) | 0 (0.0) | 1 (2.5) |
| Dry skin | 1 (2.5) | 0 (0.0) | 1 (2.5) |
Related AEs are those with a causality of possible, probable or highly probable by Investigator assessment
a
All retinopathy AEs comprised changes on ERGs, and one additional event was reported using a different term (eye disorders – other (ERG changes).
Abbreviations: AE, adverse event; CTCAE, Common Terminology Criteria for Adverse Events; TEAE, treatment emergent adverse event.