Table 2.
All emergent adverse events profile in intention-to-treat (ITT) population
| Adverse Events (AE), in alphabetical order | Guadacitabine (G) and Durvalumab (D) (ITT population n = 57) | |
|---|---|---|
| Any grade n (%) | G3/4 n (%) | |
| Abdominal pain | 14 (24.6) | 1 (1.8) |
| Anemia | 16 (28.1) | 1 (1.8) |
| Anorexia | 15 (26.3) | 1 (1.8) |
| Constipation | 11 (19.3) | |
| Cough | 14 (24.6) | |
| Diarrhea | 13 (22.8) | |
| Dyspnea | 16 (28.1) | 2 (3.5) |
| Extremities edema | 12 (21.1) | |
| Fatigue | 29 (50.9) | |
| Headache | 14 (24.6) | |
| Hyperkalemia | 12 (21.1) | |
| Hypertension | 14 (24.6) | |
| Hypothyroidism | 7 (12.3) | |
| Injection site reaction | 19 (33.3) | |
| Increased creatinine | 12 (21.1) | |
| Lipase Increased | 11 (19.3) | 6 (10.5) |
| Lymphopenia | 14 (24.6) | 3 (5.3) |
| Nausea | 16 (28.1) | 1 (1.8) |
| Neutropenia | 31 (54.4) | 22 (38.6) |
| Pain in extremity | 12 (21.1) | |
| Pruritus | 12 (21.1) | 1 (1.8) |
| Rash maculo-papular | 8 (14.0) | |
| Vomiting | 6 (10.5) | |
| Weight gain | 8 (14.0) | |
| White blood cell decreased | 25 (43.9) | 5 (8.8) |