Table 2 Summary of exposure-adjusted incidence rates of treatment-emergent adverse events during the core study and the core study + extension study (safety population)
System organ class Preferred term [n (exposure-adjusted rate)] | Core study | Core + extension study | ||||||
|---|---|---|---|---|---|---|---|---|
200CONT (n = 64) (PY = 59.4) | 200CROSS (n = 33) (PY = 30.6)a | 400CONT (n = 65) (PY = 60.2) | 400CROSS (n = 34) (PY = 31.5)a | 200CONT (n = 64) (PY = 173.6) | 200CROSS (n = 33) (PY = 61.9) | 400CONT (n = 65) (PY = 180.6) | 400CROSS (n = 34) (PY = 61.7) | |
Any TEAE | 54 (90.9) | 20 (65.4) | 56 (93.0) | 29 (92.1) | 59 (34.0) | 28 (45.2) | 62 (34.3) | 33 (53.5) |
Any serious TEAE | 3 (5.1) | 1 (3.3) | 4 (6.6) | 1 (3.2) | 11 (6.3) | 3 (4.8) | 12 (6.6) | 5 (8.1) |
Any fatal TEAE | 0 | 0 | 0 | 0 | 1 (0.6) | 0 | 0 | 0 |
Any renal-related TEAE | 4 (6.7) | 3 (9.8) | 6 (10.0) | 0 | 17 (9.8) | 2 (3.2) | 17 (9.4) | 8 (13.0) |
Any serious renal-related TEAE | 0 | 0 | 0 | 0 | 1 (0.6) | 0 | 1 (0.6) | 1 (1.6) |
Any kidney stone AE | 0 | 0 | 1 (1.7) | 1 (3.2) | 3 (1.7) | 1 (1.6) | 5 (2.8) | 2 (3.2) |
Any serious kidney stone AE | 0 | 0 | 0 | 1 (3.2) | 0 | 0 | 2 (1.1) | 1 (1.6) |
sCr elevation 1.5× baseline | 3 (5.1) | 0 | 7 (11.6) | 2 (6.3) | 10 (5.8) | 6 (9.7) | 18 (10.0) | 7 (11.3) |
sCr elevation 2.0× baseline | 2 (3.4) | 0 | 3 (5.0) | 0 | 6 (3.5) | 0 | 4 (2.2) | 4 (6.5) |
MACE | 0 | 0 | 1 (1.7) | 0 | 1 (0.6) | 0 | 2 (1.1) | 0 |
Adjudicated cardiovascular events | 3 (5.1) | 0 | 3 (5.0) | 0 | 4 (2.3) | 1 (1.6) | 4 (2.2) | 2 (3.2) |