Incidence of adverse events
| . | Cycles 1-3 . | P value . | Cycles 4-9 . | P value . | Cycles 10-15 . | P value . | |||
|---|---|---|---|---|---|---|---|---|---|
| IXZ, N = 39 . | Control, N = 34 . | IXZ, N = 24 . | Control, N = 33 . | IXZ, N = 10 . | Control, N = 22 . | ||||
| Digestive toxicity, n (%) | 14 (35.9) | 1 (2.9) | .001 | 6 (25.0) | 1 (3) | .013 | 0 (0) | 1 (4.5) | .490 |
| Grade 2 | 7 (17.9) | 0 (0) | 5 (20.8) | 1 (3) | 1 (4.5) | ||||
| Grade 3 | 7 (17.9) | 1 (2.9) | 1 (4.2) | 0 (0) | 0 (0) | ||||
| Grade 4 | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | ||||
| Peripheral neuropathy, n (%) | 0 (0) | 0 (0) | 1 (4.2) | 0 (0) | .230 | 0 (0) | 0 (0) | ||
| Grade 2 | 0 (0) | ||||||||
| Grade 3 | 1 (4.2) | ||||||||
| Grade 4 | 0 (0) | ||||||||
| Liver toxicity, n (%) | 2 (5.1) | 1 (2.9) | .632 | 5 (20.8) | 1 (3) | .031 | 2 (20) | 1 (4.5) | .164 |
| Grade 2 | 2 (5.1) | 1 (2.9) | 3 (12.5) | 1 (3) | 1 (10) | 1 (4.5) | |||
| Grade 3 | 0 (0) | 0 (0) | 2 (8.3) | 0 (0) | 1 (10) | 0 (0) | |||
| Grade 4 | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | |||
| Neutropenia, n (%) | 10 (25.6) | 1 (2.9) | .070 | 5 (20.8) | 1 (3) | .026 | 2 (20) | 3 (13.6) | .472 |
| Grade 2 | 5 (12.8) | 1 (2.9) | 3 (12.5) | 1 (3) | 1 (10) | 1 (4.5) | |||
| Grade 3 | 3 (7.7) | 0 (0) | 1 (4.2) | 0 | 1 (10) | 2 (9.1) | |||
| Grade 4 | 2 (5.1) | 0 (0) | 1 (4.2) | 0 | |||||
| Anemia, n (%) | 1 (2.6) | 4 (11.8) | .055 | 0 (0) | 1 (3) | .420 | 2 (20) | 3 (13.6) | .472 |
| Grade 2 | 0 | 3 (8.8) | 1 (3) | 1 (10) | 1 (4.5) | ||||
| Grade 3 | 1 (2.6) | 1 (2.9) | 0 | 1 (10) | 2 (9.1) | ||||
| Grade 4 | 0 | 0 | |||||||
| Thrombocytopenia, n (%) | 5 (12.8) | 1 (2.9) | .120 | 0 (0) | 2 (6.1) | .230 | 0 (0) | 0 (0) | 0 |
| Grade 2 | 4 (10.3) | 1 (2.9) | 1 (3) | ||||||
| Grade 3 | 1 (2.6) | 0 (0) | 1 (3) | ||||||
| Grade 4 | 0 (0) | 0 (0) | |||||||
| Infections, n (%) | 4 (10.3) | 3 (8.8) | .836 | 4 (16.7) | 4 (12.1) | .620 | 1 (10) | 2 (9.1%) | .935 |
| Grade 2 | 4 (10.3) | 1 (2.9) | 0 (0) | 3 (9.1) | 1 (10%) | 1 (4.5%) | |||
| Grade 3 | 0 (0) | 1 (2.9) | 3 (12.5) | 0 (0) | 1 (4.5%) | ||||
| Grade 4 | 0 (0) | 1 (2.9) | 1 (4.2) | 1 (3) | |||||
| . | Cycles 1-3 . | P value . | Cycles 4-9 . | P value . | Cycles 10-15 . | P value . | |||
|---|---|---|---|---|---|---|---|---|---|
| IXZ, N = 39 . | Control, N = 34 . | IXZ, N = 24 . | Control, N = 33 . | IXZ, N = 10 . | Control, N = 22 . | ||||
| Digestive toxicity, n (%) | 14 (35.9) | 1 (2.9) | .001 | 6 (25.0) | 1 (3) | .013 | 0 (0) | 1 (4.5) | .490 |
| Grade 2 | 7 (17.9) | 0 (0) | 5 (20.8) | 1 (3) | 1 (4.5) | ||||
| Grade 3 | 7 (17.9) | 1 (2.9) | 1 (4.2) | 0 (0) | 0 (0) | ||||
| Grade 4 | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | ||||
| Peripheral neuropathy, n (%) | 0 (0) | 0 (0) | 1 (4.2) | 0 (0) | .230 | 0 (0) | 0 (0) | ||
| Grade 2 | 0 (0) | ||||||||
| Grade 3 | 1 (4.2) | ||||||||
| Grade 4 | 0 (0) | ||||||||
| Liver toxicity, n (%) | 2 (5.1) | 1 (2.9) | .632 | 5 (20.8) | 1 (3) | .031 | 2 (20) | 1 (4.5) | .164 |
| Grade 2 | 2 (5.1) | 1 (2.9) | 3 (12.5) | 1 (3) | 1 (10) | 1 (4.5) | |||
| Grade 3 | 0 (0) | 0 (0) | 2 (8.3) | 0 (0) | 1 (10) | 0 (0) | |||
| Grade 4 | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | |||
| Neutropenia, n (%) | 10 (25.6) | 1 (2.9) | .070 | 5 (20.8) | 1 (3) | .026 | 2 (20) | 3 (13.6) | .472 |
| Grade 2 | 5 (12.8) | 1 (2.9) | 3 (12.5) | 1 (3) | 1 (10) | 1 (4.5) | |||
| Grade 3 | 3 (7.7) | 0 (0) | 1 (4.2) | 0 | 1 (10) | 2 (9.1) | |||
| Grade 4 | 2 (5.1) | 0 (0) | 1 (4.2) | 0 | |||||
| Anemia, n (%) | 1 (2.6) | 4 (11.8) | .055 | 0 (0) | 1 (3) | .420 | 2 (20) | 3 (13.6) | .472 |
| Grade 2 | 0 | 3 (8.8) | 1 (3) | 1 (10) | 1 (4.5) | ||||
| Grade 3 | 1 (2.6) | 1 (2.9) | 0 | 1 (10) | 2 (9.1) | ||||
| Grade 4 | 0 | 0 | |||||||
| Thrombocytopenia, n (%) | 5 (12.8) | 1 (2.9) | .120 | 0 (0) | 2 (6.1) | .230 | 0 (0) | 0 (0) | 0 |
| Grade 2 | 4 (10.3) | 1 (2.9) | 1 (3) | ||||||
| Grade 3 | 1 (2.6) | 0 (0) | 1 (3) | ||||||
| Grade 4 | 0 (0) | 0 (0) | |||||||
| Infections, n (%) | 4 (10.3) | 3 (8.8) | .836 | 4 (16.7) | 4 (12.1) | .620 | 1 (10) | 2 (9.1%) | .935 |
| Grade 2 | 4 (10.3) | 1 (2.9) | 0 (0) | 3 (9.1) | 1 (10%) | 1 (4.5%) | |||
| Grade 3 | 0 (0) | 1 (2.9) | 3 (12.5) | 0 (0) | 1 (4.5%) | ||||
| Grade 4 | 0 (0) | 1 (2.9) | 1 (4.2) | 1 (3) | |||||