GI nuisance symptoms
|
GI nuisance AEs | 14 (12.5) | 50 (11.2) | 102 (23.2) | 54 (12.4) | 51 (12.6) | 19 (7.7) | 31 (14.3) |
Discontinuations | 2 (1.8) | 5 (1.1) | 18 (4.1) | 6 (1.4) | 8 (2.0) | 0 (0.0) | 3 (1.4) |
| | | | | | | |
Renovascular AEs
| | | | | | | |
Hypertension | 7 (6.3) | 23 (5.2) | 13 (3.0) | 32 (7.4) | 17 (4.2) | 27 (11.0) | 23 (10.6) |
Discontinuations | 0 (0.0) | 1 (0.2) | 1 (0.2) | 1 (0.2) | 0 (0.0) | 1 (0.4) | 0 (0.0) |
Lower extremity oedema | 2 (1.8) | 10 (2.2) | 9 (2.1) | 10 (2.3) | 13 (3.2) | 8 (3.3) | 7 (3.2) |
Discontinuations | 1 (0.9) | 0 (0.0) | 0 (0.0) | 1 (0.2) | 0 (0.0) | 1 (0.4) | 0 (0.0) |
Congestive heart failure | 0 (0.0) | 0 (0.0) | 1 (0.2) | 0 (0.0) | 2 (0.5) | 0 (0.0) | 2 (0.9) |
Discontinuations | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (0.3) | 0 (0.0) | 0 (0.0) |
|
Confirmed serious thrombotic CV AEs and upper GI bleeding AEs
|
Confirmed serious thrombotic CV AEs | 0 (0.0) | 1 (0.2) | 0 (0.0) | 10 (2.3) | 2 (0.5) | 2 (0.8) | 4 (1.8) |
Confirmed upper GI bleeding AEs | 0 (0.0) | 0 (0.0) | 7 (1.6) | 5 (1.2) | 11 (2.7) | 2 (0.8) | 13 (5.9) |