Incidence of TEAEs (≥15% of patients) and selected laboratory abnormalities by cohort type (combined primary and extension studies)
| . | Idela + R (n = 32) . | Idela + B (n = 33) . | Idela + BR (n = 14) . | Total (n = 79) . | ||||
|---|---|---|---|---|---|---|---|---|
| Grade . | Grade . | Grade . | Grade . | |||||
| Any . | ≥3 . | Any . | ≥3 . | Any . | ≥3 . | Any . | ≥3 . | |
| AE, n (%) | 32 (100) | 26 (81) | 33 (100) | 32 (97) | 14 (100) | 12 (86) | 79 (100) | 70 (89) |
| Pyrexia | 12 (37) | 0 | 21 (64) | 1 (3) | 10 (71) | 1 (7) | 43 (54) | 2 (2) |
| Nausea | 13 (41) | 0 | 13 (39) | 0 | 9 (64) | 0 | 35 (44) | 0 |
| Fatigue | 12 (37) | 1 (3) | 16 (48) | 2 (6) | 6 (43) | 0 | 34 (43) | 3 (4) |
| Rash | 8 (25) | 2 (6) | 13 (39) | 2 (6) | 9 (64) | 3 (21) | 30 (38) | 7 (9) |
| Diarrhea/colitis | 13 (41) | 6 (19) | 11 (33) | 3 (9) | 5 (36) | 3 (21) | 29 (37) | 12 (15) |
| Cough | 11 (34) | 0 | 13 (39) | 0 | 4 (29) | 0 | 28 (35) | 0 |
| Insomnia | 7 (22) | 0 | 10 (30) | 0 | 1 (7) | 0 | 18 (23) | 0 |
| Upper respiratory infection | 7 (22) | 0 | 8 (24) | 1 (3) | 1 (7) | 0 | 16 (20) | 1 (1) |
| Pneumonia | 4 (12) | 4 (12) | 10 (30) | 10 (30) | 3 (21) | 1 (7) | 17 (22) | 15 (19) |
| Chills | 4 (12) | 0 | 9 (27) | 0 | 1 (7) | 0 | 14 (18) | 0 |
| Vomiting | 3 (9) | 0 | 6 (18) | 1 (3) | 5 (36) | 0 | 14 (18) | 1 (1) |
| Constipation | 2 (6) | 0 | 7 (21) | 1 (3) | 3 (21) | 0 | 12 (15) | 1 (1) |
| Headache | 7 (22) | 0 | 4 (12) | 0 | 1 (7) | 0 | 12 (15) | 0 |
| Chemistry laboratory abnormality, n (%) | ||||||||
| ALT, increased | 13 (41) | 5 (16) | 19 (58) | 8 (24) | 4 (29) | 0 | 36 (46) | 13 (16) |
| AST, increased | 18 (56) | 4 (13) | 19 (58) | 5 (15) | 4 (29) | 0 | 41 (52) | 9 (11) |
| Alkaline phosphatase, increased | 12 (38) | 1 (3) | 20 (61) | 0 | 3 (21) | 0 | 35 (44) | 1 (1) |
| Bilirubin, increased | 7 (22) | 0 | 9 (27) | 0 | 3 (21) | 0 | 19 (24) | 0 |
| Creatinine, increased | 7 (22) | 0 | 3 (9) | 0 | 3 (21) | 0 | 13 (16) | 0 |
| Hematology laboratory abnormality, n (%) | ||||||||
| Lymphocytes, decreased | 18 (56) | 12 (38) | 28 (85) | 25 (76) | 13 (93) | 12 (86) | 59 (75) | 49 (62) |
| Neutrophils, decreased | 14 (44) | 11 (34) | 21 (64) | 15 (46) | 9 (64) | 6 (43) | 44 (56) | 32 (41) |
| Hemoglobin, decreased | 6 (19) | 2 (6) | 24 (73) | 5 (15) | 7 (50) | 1 (7) | 37 (47) | 8 (10) |
| Platelets, decreased | 8 (25) | 1 (3) | 19 (58) | 4 (12) | 6 (43) | 1 (7) | 33 (42) | 6 (8) |
| . | Idela + R (n = 32) . | Idela + B (n = 33) . | Idela + BR (n = 14) . | Total (n = 79) . | ||||
|---|---|---|---|---|---|---|---|---|
| Grade . | Grade . | Grade . | Grade . | |||||
| Any . | ≥3 . | Any . | ≥3 . | Any . | ≥3 . | Any . | ≥3 . | |
| AE, n (%) | 32 (100) | 26 (81) | 33 (100) | 32 (97) | 14 (100) | 12 (86) | 79 (100) | 70 (89) |
| Pyrexia | 12 (37) | 0 | 21 (64) | 1 (3) | 10 (71) | 1 (7) | 43 (54) | 2 (2) |
| Nausea | 13 (41) | 0 | 13 (39) | 0 | 9 (64) | 0 | 35 (44) | 0 |
| Fatigue | 12 (37) | 1 (3) | 16 (48) | 2 (6) | 6 (43) | 0 | 34 (43) | 3 (4) |
| Rash | 8 (25) | 2 (6) | 13 (39) | 2 (6) | 9 (64) | 3 (21) | 30 (38) | 7 (9) |
| Diarrhea/colitis | 13 (41) | 6 (19) | 11 (33) | 3 (9) | 5 (36) | 3 (21) | 29 (37) | 12 (15) |
| Cough | 11 (34) | 0 | 13 (39) | 0 | 4 (29) | 0 | 28 (35) | 0 |
| Insomnia | 7 (22) | 0 | 10 (30) | 0 | 1 (7) | 0 | 18 (23) | 0 |
| Upper respiratory infection | 7 (22) | 0 | 8 (24) | 1 (3) | 1 (7) | 0 | 16 (20) | 1 (1) |
| Pneumonia | 4 (12) | 4 (12) | 10 (30) | 10 (30) | 3 (21) | 1 (7) | 17 (22) | 15 (19) |
| Chills | 4 (12) | 0 | 9 (27) | 0 | 1 (7) | 0 | 14 (18) | 0 |
| Vomiting | 3 (9) | 0 | 6 (18) | 1 (3) | 5 (36) | 0 | 14 (18) | 1 (1) |
| Constipation | 2 (6) | 0 | 7 (21) | 1 (3) | 3 (21) | 0 | 12 (15) | 1 (1) |
| Headache | 7 (22) | 0 | 4 (12) | 0 | 1 (7) | 0 | 12 (15) | 0 |
| Chemistry laboratory abnormality, n (%) | ||||||||
| ALT, increased | 13 (41) | 5 (16) | 19 (58) | 8 (24) | 4 (29) | 0 | 36 (46) | 13 (16) |
| AST, increased | 18 (56) | 4 (13) | 19 (58) | 5 (15) | 4 (29) | 0 | 41 (52) | 9 (11) |
| Alkaline phosphatase, increased | 12 (38) | 1 (3) | 20 (61) | 0 | 3 (21) | 0 | 35 (44) | 1 (1) |
| Bilirubin, increased | 7 (22) | 0 | 9 (27) | 0 | 3 (21) | 0 | 19 (24) | 0 |
| Creatinine, increased | 7 (22) | 0 | 3 (9) | 0 | 3 (21) | 0 | 13 (16) | 0 |
| Hematology laboratory abnormality, n (%) | ||||||||
| Lymphocytes, decreased | 18 (56) | 12 (38) | 28 (85) | 25 (76) | 13 (93) | 12 (86) | 59 (75) | 49 (62) |
| Neutrophils, decreased | 14 (44) | 11 (34) | 21 (64) | 15 (46) | 9 (64) | 6 (43) | 44 (56) | 32 (41) |
| Hemoglobin, decreased | 6 (19) | 2 (6) | 24 (73) | 5 (15) | 7 (50) | 1 (7) | 37 (47) | 8 (10) |
| Platelets, decreased | 8 (25) | 1 (3) | 19 (58) | 4 (12) | 6 (43) | 1 (7) | 33 (42) | 6 (8) |
TEAEs classified by PT using MedDRA, version 15.1. Patients who experienced multiple events within the same PT were counted once per PT.
PT, preferred term.