Most common treatment emergent adverse effects in all patients
| TEAEs ≥5% . | 8-day Ven (n = 14) . | 11-day Ven (n = 9) . | 14-day Ven (n = 11) . | All cohorts (N = 34) . | ||||
|---|---|---|---|---|---|---|---|---|
| Any grade, n (%) . | Grade ≥3, n (%) . | Any grade, n (%) . | Grade ≥3, n (%) . | Any grade, n (%) . | Grade ≥3, n (%) . | Any grade, n (%) . | Grade ≥3, n (%) . | |
| WBC/ANC decreased | 14 (100) | 14 (100) | 9 (100) | 9 (100) | 11 (100) | 11 (100) | 34 (100) | 34 (100) |
| Anemia | 14 (100) | 14 (100) | 9 (100) | 9 (100) | 11 (100) | 11 (100) | 34 (100) | 34 (100) |
| PLT decreased | 14 (100) | 14 (100) | 9 (100) | 9 (100) | 11 (100) | 11 (100) | 34 (100) | 34 (100) |
| Neutropenic fever | 14 (100) | 14 (100) | 9 (100) | 9 (100) | 11 (100) | 11 (100) | 34 (100) | 34 (100) |
| NEC | 3 (21) | 3 (21) | 1 (11) | 1 (11) | 4 (36) | 4 (36) | 8 (23.5) | 8 (23.5) |
| Sepsis/bacteremia | 5 (36) | 5 (36) | — | — | 5 (45.5) | 5 (45.5) | 10 (29) | 10 (29) |
| Lung infection | 2 (14) | 2 (14) | 1 (11) | 1 (11) | 3 (27) | 3 (27) | 6 (18) | 6 (18) |
| Soft tissue infection | 2 (14) | 2 (14) | — | — | — | — | 2 (6) | 2 (6) |
| Skin infection | 1 (7) | 1 (7) | 1 (11) | — | — | — | 2 (6) | 1 (3) |
| Infectious colitis | 1 (7) | — | — | — | 2 (18) | 2 (18) | 3 (9) | 2 (6) |
| Joint infection | — | — | — | — | 1 (9) | 1 (9) | 1 (3) | 1 (3) |
| Fungemia | — | — | — | — | 1 (9) | 1 (9) | 1 (3) | 1 (3) |
| Nausea | 7 (50) | — | 3 (33) | — | 6 (54.5) | — | 16 (47) | — |
| Vomiting | 3 (21) | — | — | — | 5 (45.5) | — | 8 (23.5) | — |
| Diarrhea | 6 (43) | — | 6 (67) | — | 3 (27) | — | 15 (44) | — |
| Mucositis oral | 1 (7) | 1 (7) | 4 (44) | 1 (11) | 1 (9) | 1 (9) | 6 (18) | 3 (9) |
| Alk Phos increased | 11 (79) | — | 7 (78) | 1 (11) | 9 (82) | 3 (27) | 27 (79) | 4 (12) |
| ALT increased | 7 (50) | — | 3 (33) | 1 (11) | 7 (64) | 2 (18) | 17 (50) | 3 (9) |
| AST Increased | 10 (71) | 1 (7) | 7 (78) | — | 9 (82) | 1 (9) | 26 (76.5) | 2 (6) |
| Hypokalemia | 10 (71) | 5 (36) | 6 (67) | 1 (11) | 9 (82) | 3 (27) | 25 (73.5) | 9 (26.5) |
| Hyponatremia | 6 (43) | 1 (7) | 2 (22) | — | 6 (54.5) | — | 14 (41) | 1 (3) |
| TEAEs ≥5% . | 8-day Ven (n = 14) . | 11-day Ven (n = 9) . | 14-day Ven (n = 11) . | All cohorts (N = 34) . | ||||
|---|---|---|---|---|---|---|---|---|
| Any grade, n (%) . | Grade ≥3, n (%) . | Any grade, n (%) . | Grade ≥3, n (%) . | Any grade, n (%) . | Grade ≥3, n (%) . | Any grade, n (%) . | Grade ≥3, n (%) . | |
| WBC/ANC decreased | 14 (100) | 14 (100) | 9 (100) | 9 (100) | 11 (100) | 11 (100) | 34 (100) | 34 (100) |
| Anemia | 14 (100) | 14 (100) | 9 (100) | 9 (100) | 11 (100) | 11 (100) | 34 (100) | 34 (100) |
| PLT decreased | 14 (100) | 14 (100) | 9 (100) | 9 (100) | 11 (100) | 11 (100) | 34 (100) | 34 (100) |
| Neutropenic fever | 14 (100) | 14 (100) | 9 (100) | 9 (100) | 11 (100) | 11 (100) | 34 (100) | 34 (100) |
| NEC | 3 (21) | 3 (21) | 1 (11) | 1 (11) | 4 (36) | 4 (36) | 8 (23.5) | 8 (23.5) |
| Sepsis/bacteremia | 5 (36) | 5 (36) | — | — | 5 (45.5) | 5 (45.5) | 10 (29) | 10 (29) |
| Lung infection | 2 (14) | 2 (14) | 1 (11) | 1 (11) | 3 (27) | 3 (27) | 6 (18) | 6 (18) |
| Soft tissue infection | 2 (14) | 2 (14) | — | — | — | — | 2 (6) | 2 (6) |
| Skin infection | 1 (7) | 1 (7) | 1 (11) | — | — | — | 2 (6) | 1 (3) |
| Infectious colitis | 1 (7) | — | — | — | 2 (18) | 2 (18) | 3 (9) | 2 (6) |
| Joint infection | — | — | — | — | 1 (9) | 1 (9) | 1 (3) | 1 (3) |
| Fungemia | — | — | — | — | 1 (9) | 1 (9) | 1 (3) | 1 (3) |
| Nausea | 7 (50) | — | 3 (33) | — | 6 (54.5) | — | 16 (47) | — |
| Vomiting | 3 (21) | — | — | — | 5 (45.5) | — | 8 (23.5) | — |
| Diarrhea | 6 (43) | — | 6 (67) | — | 3 (27) | — | 15 (44) | — |
| Mucositis oral | 1 (7) | 1 (7) | 4 (44) | 1 (11) | 1 (9) | 1 (9) | 6 (18) | 3 (9) |
| Alk Phos increased | 11 (79) | — | 7 (78) | 1 (11) | 9 (82) | 3 (27) | 27 (79) | 4 (12) |
| ALT increased | 7 (50) | — | 3 (33) | 1 (11) | 7 (64) | 2 (18) | 17 (50) | 3 (9) |
| AST Increased | 10 (71) | 1 (7) | 7 (78) | — | 9 (82) | 1 (9) | 26 (76.5) | 2 (6) |
| Hypokalemia | 10 (71) | 5 (36) | 6 (67) | 1 (11) | 9 (82) | 3 (27) | 25 (73.5) | 9 (26.5) |
| Hyponatremia | 6 (43) | 1 (7) | 2 (22) | — | 6 (54.5) | — | 14 (41) | 1 (3) |
Alk Phos, alkaline phosphatase; ALT, alanine aminotransferase; ANC, absolute neutrophil count; AST, aspartate aminotransferase; TEAE, treatment emergent adverse effects; WBC, white blood cells.