Table 3. AE groups of special interesta.
| Patients,n(%) | Consolidation phase (n=190)b | TFR phase (n=190)b |
|---|---|---|
| Musculoskeletal painc | 31 (16.3) | 47 (24.7) |
| Fluid retention | 4 (2.1) | 8 (4.2) |
| Cardiovascular events | 4 (2.1) | 5 (2.6) |
| Ischemic cerebrovascular events | 1 (0.5) | 2 (1.1) |
| Ischemic heart disease | 2 (1.1) | 0 |
| Peripheral artery disease | 1 (0.5) | 2 (1.1) |
| Others | 0 | 1 (0.5) |
| Rash | 8 (4.2) | 2 (1.1) |
| Pancreatitis | 3 (1.6) | 0 |
Abbreviations: AE, adverse event; TFR, treatment-free remission.
a
Each listed AE group includes a predefined set of individual AEs. Reported frequencies include all patients with ⩾1 AE in the group.
b
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.
c
Defined as any of the following AEs: musculoskeletal pain, myalgia, pain in extremity, arthralgia, bone pain and/or spinal pain.