MedDRA Preferred Term | Cohort 3 (Bel D1-3) n = 8 n (%) | Cohort 5 + Expansion (Bel D1-5) n = 15 n (%) | Total N = 23 n (%) | ||||||
---|---|---|---|---|---|---|---|---|---|
All Grades | Grade 1–2 | Grade 3–4 | All Grades | Grade 1–2 | Grade 3–4 | All Grades | Grade 1–2 | Grade 3–4 | |
All AEs (> 25% of pts) | 8 (100) | 0 | 8 (100) | 15 (100) | 5 (33) | 10 (67) | 23 (100) | 5 (22) | 18 (78) |
Nausea | 6 (75) | 6 (75) | 1 (13) | 12 (80) | 12 (80) | 1 (7) | 18 (78) | 18 (78) | 2 (9) |
Fatigue | 7 (88) | 7 (88) | 0 | 7 (47) | 7 (47) | 0 | 14 (61) | 14 (61) | 0 |
Vomiting | 4 (50) | 4 (50) | 0 | 9 (60) | 9 (60) | 0 | 13 (57) | 13 (57) | 0 |
Anemia | 4 (50) | 3 (38) | 2 (25) | 5 (33) | 4 (27) | 3 (20) | 9 (39) | 7 (30) | 5 (22) |
Constipation | 2 (25) | 2 (25) | 0 | 7 (47) | 7 (47) | 0 | 9 (39) | 9 39) | 0 |
Diarrhea | 4 (50) | 3 (38) | 0 | 5 (33) | 5 (33) | 0 | 9 (39) | 8 (35) | 0 |
Alopecia | 4 (50) | 4 (50) | 0 | 4 (27) | 4 (27) | 0 | 8 (35) | 8 (35) | 0 |
Decreased appetite | 3 (38) | 3 (38) | 0 | 5 (33) | 5 (33) | 0 | 8 (35) | 8 (35) | 0 |
Dizziness | 2 (25) | 2 25) | 0 | 6 (40) | 6 (40) | 0 | 8 (35) | 8 (35) | 0 |
Cough | 3 (38) | 3 (38) | 0 | 4 (27) | 4 (27) | 0 | 7 (30) | 7 (30) | 0 |
Dysphonia | 3 (38) | 2 (25) | 0 | 4 (27) | 3 (20) | 0 | 7 (30) | 5 (22) | 0 |
Neutrophil count decreased | 3 (38) | 1 (13) | 3 (38) | 4 (27) | 1 (7) | 4 (27) | 7 (30) | 2 (9) | 7 (30) |
Stomatitis | 3 (38) | 3 (38) | 0 | 4 (27) | 4 (27) | 0 | 7 (30) | 7 (30) | 0 |
Upper respiratory tract infection | 2 (25) | 2 (25) | 0 | 5 (33) | 4 (27) | 0 | 7 (30) | 6 (26) | 0 |
Headache | 4 (50) | 4 (50) | 0 | 2 (13) | 2 (13) | 0 | 6 (26) | 6 (26) | 0 |
Neutropenia | 3 (38) | 1 (13) | 3 (38) | 3 (20) | 1 (7) | 3 (20) | 6 (26) | 2 (9) | 6 (26) |
Pruritus | 2 (25) | 1 (13) | 0 | 4 (27) | 0 (0) | 0 | 6 (26) | 1 (4) | 0 |
Pyrexia | 3 (38) | 3 (38 | 0 | 3 (20) | 3 (20) | 0 | 6 (26) | 6 (26) | 0 |
WBC count decreased | 2 (25) | 0 | 2 (25) | 4 (27) | 2 13) | 3 (20) | 6 (26) | 2 (9) | 5 (22) |
Related AEs (> 25% of pts) | 7 (88) | 2 (25) | 5 (63) | 15 (100) | 7 (47) | 8 (53) | 22 (96) | 9 (39) | 13 (57) |
Nausea | 5 (63) | 5 (63) | 1 (13) | 11 (73) | 11 (73) | 1 (7) | 16 (70) | 16 (70) | 2 (9) |
Fatigue | 7 (88) | 7 (88) | 0 | 6 (40) | 6 (40) | 0 | 13 (57) | 13 (57) | 0 |
Vomiting | 4 (50) | 4 (50) | 1 (13) | 9 (60) | 9 (60) | 0 | 13 (57) | 13 (57) | 1 (4) |
Anemia | 3 (38) | 2 (25) | 2 (25) | 5 (33) | 4 (27) | 2 (13) | 8 (35) | 6 (26) | 4 (17) |
Constipation | 2 (25) | 2 (25) | 1 (13) | 6 (40) | 6 (40) | 0 | 8 (35) | 8 (35) | 1 (4) |
Diarrhea | 4 (50) | 3 (38) | 1 (13) | 4 (27) | 4 (27) | 0 | 8 (35) | 7 (30) | 1 (4) |
Neutrophil count decreased | 3 (38) | 1 (13) | 3 (38) | 4 (27) | 1 (7) | 4 (27) | 7 (30) | 2 (9) | 7 (30) |
Decreased appetite | 2 (25) | 2 (25) | 1 (13) | 4 (27) | 4 (27) | 0 | 6 (26) | 6 (26) | 1 (4) |
Stomatitis | 3 (38) | 3 (38) | 0 | 3 (20) | 3 (20) | 0 | 6 (26) | 6 (26) | 0 |
SAEs (> 1 pt)a | 3 (38) | 2 (25) | 2 (25) | 7 (47) | 2 (13) | 7 (47) | 10 (43) | 4 (17) | 9 (39) |
Febrile neutropenia | 1 (13) | 1 (13) | 1 (13) | 3 (20) | 0 | 3 (20) | 4 (17) | 0 | 4 (17) |
Pyrexia | 2 (25) | 2 (25) | 0 | 1 (7) | 1 (7) | 0 | 3 (13) | 3 (13) | 0 |
Nausea | 1 (13) | 0 | 1 (13) | 1 (7) | 0 | 1 (7) | 2 (9) | 0 | 1 (4) |
Neutropenia | 0 | 0 | 0 | 2 (13) | 0 | 2 (13) | 2 (9) | 0 | 2 (9) |
Discontinuation due to AE | 1 (13) | 0 | 1 (13)b | 0 | 0 | 0 | 1 (4) | 0 | 1 (4)b |
Respiratory failure (fatal) secondary to PD | 1 (13) | 0 | 1 (13)b | 0 | 0 | 0 | 1 (4) | 0 | 1 (4)b |