Table 2.
Incidence of OXi4503-related Grade 3–4 AEs (adverse events) occurring in study OX1222 patients treated with OXA—by MedDRA PT.
| MedDRA SOC MedDRA PT |
Cohorts (Number of Patients/Cohort) n (%) |
Total | |||||
|---|---|---|---|---|---|---|---|
| 3.75 mg/m2 (7) | 4.68 mg/m2 (4) | 6.25 mg/m2 (4) | 7.81 mg/m2 (3) | 9.76 mg/m2 (7) | 12.2 mg/m2 (4) | (N = 29) n (%) | |
| Blood and Lymphatic System Disorders | |||||||
| Anemia | 1 (14.3) | 1 (25) | 0 | 1 (33.3) | 1 (14.3) | 0 | 4 (13.8) |
| Grade 3 | 0 | 1 (25) | 0 | 1 | 1(14.3) | 0 | 3 (10.3) |
| Grade 4 | 1 (14.3) | 0 | 0 | 0 | 0 | 0 | 1 (3.4) |
| Blood Bilirubin Increased | 0 | 0 | 0 | 0 | 0 | 1 (25) | 1 (3.4) |
| Grade 3 | 0 | 0 | 0 | 0 | 0 | 1(25) | 1 (3.4) |
| Febrile Neutropenia | 0 | 1 (25) | 2 (50) | 3 (100) | 1 (14.3) | 1 (25) | 8 (27.6) |
| Grade 3 | 0 | 1(25) | 2 (50) | 3 (100) | 1 (14.3) | 1 (25) | 8 (27.6) |
| Neutropenia | 0 | 1 (25) | 0 | 0 | 0 | 0 | 1 (3.4) |
| Grade 4 | 0 | 1(25) | 0 | 0 | 0 | 0 | 1 (3.4) |
| Thrombocytopenia | 0 | 1 (25) | 0 | 0 | 0 | 0 | 1 (3.4) |
| Grade 4 | 0 | 1 (25) | 0 | 0 | 0 | 0 | 1 (3.4) |
| Infections and Infestations | |||||||
| Bacteremia | 0 | 0 | 0 | 1 (33.3) | 0 | 0 | 1 (3.4) |
| Grade 3 | 0 | 0 | 0 | 1(33.3) | 0 | 0 | 1 (3.4) |
| Pneumonia | 0 | 0 | 0 | 0 | 0 | 1 (25) | 1 (3.4) |
| Grade 3 | 0 | 0 | 0 | 0 | 0 | 1 (25) | 1 (3.4) |
| Investigations | |||||||
| Aspartate Aminotransferase Increased | 1 (14.3) | 0 | 0 | 0 | 0 | 1 (25) | 2 (6.9) |
| Grade 3 | 1 (14.3) | 0 | 0 | 0 | 0 | 1 (25) | 2 (6.9) |
| Blood Bilirubin Increased | 0 | 0 | 0 | 0 | 0 | 1 (25) | 1 (3.4) |
| Grade 3 | 0 | 0 | 0 | 0 | 0 | 1 (25) | 1 (3.4) |
| Blood Fibrinogen Decreased | 1 (14.3) | 0 | 0 | 0 | 0 | 0 | 1 (3.4) |
| Grade 3 | 1 (14.3) | 0 | 0 | 0 | 0 | 0 | 1 (3.4) |
| Neutrophil Count Decreased | 2 (28.6) | 0 | 0 | 1 (33.3) | 1 (14.3) | 0 | 4 (13.8) |
| Grade 3 | 1 (14.3) | 0 | 0 | 0 | 1 (14.3) | 0 | 2 (6.9) |
| Grade 4 | 1 (14.3) | 0 | 0 | 1 (33.3) | 0 | 0 | 2 (6.9) |
| Platelet Count Decreased | 1 (14.3) | 1 (25) | 0 | 1 (33.3) | 1 (14.3) | 0 | 5 (17.2) |
| Grade 3 | 0 | 0 | 0 | 0 | 1(14.3) | 0 | 1 (3.4) |
| Grade 4 | 2 (28.6) | 1 (25) | 0 | 1 (33.3) | 0 | 0 | 4 (13.8) |
| Prothrombin Time Prolonged | 1 (14.3) | 0 | 0 | 0 | 0 | 0 | 1 (3.4) |
| Grade 3 | 1 (14.3) | 0 | 0 | 0 | 0 | 0 | 1 (3.4) |
| White blood Cell Count Decreased | 0 | 0 | 0 | 1 (33.3) | 1 (14.3) | 0 | 2 (6.9) |
| Grade 4 | 0 | 0 | 0 | 1 (33.3) | 1 (14.3) | 0 | 2 (6.9) |
| Metabolism and Nutrition Disorders | |||||||
| Hypokalemia | 1 (14.3) | 0 | 0 | 0 | 0 | 0 | 1 (3.4) |
| Grade 3 | 1 (14.3) | 0 | 0 | 0 | 0 | 0 | 1 (3.4) |
| Respiratory, Thoracic and Mediastinal Disorders | |||||||
| Respiratory Failure | 0 | 0 | 0 | 0 | 0 | 1 (25) | 1 (3.4) |
| Grade 4 | 0 | 0 | 0 | 0 | 0 | 1 (25) | 1 (3.4) |
| Vascular Disorders | |||||||
| Hypertension | 1 (14.3) | 0 | 0 | 1 (33.3) | 1 (14.3) | 2 (50) | 5 (17.2) |
| Grade 3 | 1 (14.3) | 0 | 0 | 1 (33.3) | 1 (14.3) | 2 (50) | 5 (17.2) |
| Hypotension | 0 | 0 | 0 | 0 | 0 | 1 (25) | 1 (3.4) |
| Grade 3 | 0 | 0 | 0 | 0 | 0 | 1 (25) | 1 (3.4) |
Multiple events for the same term and patient have been reported as 1 event only, unless same event was reported for 2 different Grades i.e., worsened Depicted are patient numbers in each cohort and their percentage experiencing Grade 3–4 AE as well as the total number of the Grade 3–4 AE and their percentage in the entire patient population across all dose cohorts.