Table 2.
Summary of TEAEs
| Part A Total (N = 14) n (%); no. of events |
Cohort 1 - Pancreatic (N = 8) n (%); no. of events |
Cohort 2 - Esophageal (N = 7) n (%); no. of events |
Cohort 3 - Gastric (N = 8) n (%); no. of events |
Cohort 4 - Colorectal (N = 9) n (%); no. of events |
Cohort 5 - Basket (N = 8) n (%); no. of events |
Part B Total (N = 40) n (%); no. of events |
Study Total (Parts A and B) (N = 54) n (%); no. of events |
|
|---|---|---|---|---|---|---|---|---|
| TEAEs | 13 (92.9); 87 | 8 (100); 79 | 6 (85.7); 24 | 8 (100); 57 | 9 (100); 53 | 8 (100); 65 | 39 (97.5); 278 | 52 (96.3); 365 |
| TEAEs grade ≥ 3 | 3 (21.4); 5 | 6 (75.0); 23 | 3 (42.9); 6 | 5 (62.5); 15 | 4 (44.4); 6 | 4 (50.0); 13 | 22 (55.0); 63 | 25 (46.3); 68 |
| TEAEs related to OBI-888 | 7 (50.0); 24 | 5 (62.5); 17 | 2 (28.6); 3 | 2 (25.0); 2 | 5 (55.6); 26 | 5 (62.5); 7 | 19 (47.5); 55 | 26 (48.1); 79 |
| TEAEs leading to discontinuation of OBI-888 | 0 | 2 (25.0); 7 | 1 (14.3); 1 | 0 | 2 (22.2); 3 | 0 | 5 (12.5); 11 | 5 (9.3); 11 |
| TEAEs leading to death | 0 | 1 (12.5); 1 | 0 | 0 | 1 (11.1); 1 | 0 | 2 (5.0); 2 | 2 (3.7); 2 |
| Serious TEAEs | 2 (14.3); 3 | 4 (50.0); 9 | 2 (28.6); 2 | 5 (62.5); 11 | 4 (44.4); 5 | 2 (25.0); 12 | 17 (42.5); 39 | 19 (35.2); 42 |
| Serious TEAEs related to OBI-888 | 0 | 1 (12.5); 1 | 0 | 0 | 0 | 0 | 1 (2.5); 1 | 1 (1.9); 1 |
| Serious TEAEs leading to discontinuation of OBI-888 | 0 | 2 (25.0); 4 | 1 (14.3); 1 | 0 | 1 (11.1); 1 | 0 | 4 (10.0); 6 | 4 (7.4); 6 |
TEAE, treatment-emergent adverse event