Table 2. Frequently reported AEs and laboratory abnormalities in the TFR population during the consolidation and TFR phases.
| Patients,n(%) |
Consolidation phase (n=190)a |
TFR phase (n=190)a |
||
|---|---|---|---|---|
| Any grade | Grade 3/4 | Any grade | Grade 3/4 | |
| AEs reported in >5% of patients in the consolidation or TFR phase | ||||
| Nasopharyngitis | 21 (11.1) | 0 | 16 (8.4) | 0 |
| Arthralgia | 16 (8.4) | 0 | 23 (12.1) | 2 (1.1) |
| Hypertension | 15 (7.9) | 10 (5.3) | 7 (3.7) | 2 (1.1) |
| Diarrhea | 11 (5.8) | 0 | 8 (4.2) | 1 (0.5) |
| Headache | 10 (5.3) | 0 | 10 (5.3) | 0 |
| Pain in extremity | 5 (2.6) | 0 | 12 (6.3) | 0 |
| Key hematologic abnormalities based on CTCAE grades of laboratory values | ||||
| Anemia | 46 (24.2) | 0 | 38 (20.0) | 1 (0.5) |
| Lymphopenia | 17 (8.9) | 1 (0.5) | 26 (13.7) | 0 |
| Thrombocytopenia | 16 (8.4) | 0 | 20 (10.5) | 0 |
| Leukopenia | 5 (2.6) | 0 | 11 (5.8) | 1 (0.5) |
| Key biochemical abnormalities based on CTCAE grades of laboratory values | ||||
| Elevated glucose | 75 (39.5) | 1 (0.5) | 37 (19.5) | 1 (0.5) |
| Elevated ALT | 71 (37.4) | 0 | 24 (12.6) | 0 |
| Elevated AST | 30 (15.8) | 0 | 13 (6.8) | 0 |
| Elevated bilirubin | 57 (30.0) | 3 (1.6) | 6 (3.2) | 0 |
| Elevated lipase | 57 (30.0) | 6 (3.2) | 22 (11.6) | 3 (1.6) |
Abbreviations: AE, adverse event; ALT, alanine aminotransferase; AST, aspartate aminotransferase; CTCAE, Common Terminology Criteria for Adverse Events; TFR, treatment-free remission.
a
Median duration of study treatment during the consolidation phase among patients in the TFR population was 52 weeks, and the duration of the TFR phase was 48 weeks.