Grade 3 or 4 AEs of special interest in the Japanese subgroup versus the overall population (safety population)
| n (%) . | Japanese subgroup . | Overall population . | ||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| . | AAP (n = 35) . | Placebo (n = 35) . | Placebo-AAP (n = 3) . | AAP (n = 597) . | Placebo (n = 602) . | Placebo-AAP (n = 72) . | ||||||||||||
| . | All grades . | Grade 3 . | Grade 4 . | All grades . | Grade 3 . | Grade 4 . | All grades . | Grade 3 . | Grade 4 . | All grades . | Grade 3 . | Grade 4 . | All grades . | Grade 3 . | Grade 4 . | All grades . | Grade 3 . | Grade 4 . |
| Mineralocorticoid-related AEs | ||||||||||||||||||
| Hypertension | 18 (51.4) | 12 (34.3) | 0 | 8 (22.9) | 2 (5.7) | 0 | 0 | 0 | 0 | 229 (38.4) | 125 (20.9) | 0 | 133 (22.1) | 59 (9.8) | 1 (0.2) | 4 (5.6) | 3 (4.2) | 0 |
| Hypokalemia | 15 (42.9) | 4 (11.4) | 1 (2.9) | 0 | 0 | 0 | 0 | 0 | 0 | 143 (24.0) | 65 (10.9) | 5 (0.8) | 23 (3.8) | 9 (1.5) | 1 (0.2) | 9 (12.5) | 2 (2.8) | 0 |
| Hepatotoxicity | 13 (37.1) | 3 (8.6) | 0 | 13 (37.1) | 1 (2.9) | 0 | 1 (33.3) | 1 (33.3) | 0 | 146 (24.5) | 49 (8.2) | 4 (0.7) | 109 (18.1) | 21 (3.5) | 0 | 7 (9.7) | 3 (4.2) | 0 |
| Cataract | 3 (8.6) | 2 (5.7) | 0 | 1 (2.9) | 1 (2.9) | 0 | 0 | 0 | 0 | 15 (2.5) | 8 (1.3) | 0 | 4 (0.7) | 1 (0.2) | 0 | 0 | 0 | 0 |
| Osteoporosis including osteoporosis-related fractures | 8 (22.9) | 1 (2.9) | 0 | 2 (5.7) | 0 | 0 | 0 | 0 | 0 | 43 (7.2) | 9 (1.5) | 0 | 27 (4.5) | 13 (2.2) | 1 (0.2) | 1 (1.4) | 0 | 0 |
| Fluid retention/oedema Cardiac | 1 (2.9) | 0 | 0 | 5 (14.3) | 0 | 0 | 0 | 0 | 0 | 81 (13.6) | 5 (0.8) | 0 | 71 (11.8) | 6 (1.0) | 0 | 3 (4.2) | 0 | 0 |
| Any | 4 (11.4) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 95 (15.9) | 18 (3.0) | 5 (0.8) | 52 (8.6) | 6 (1.0) | 0 | 1 (1.4) | 0 | 0 |
| Arrhythmia | 3 (8.6) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 49 (8.2) | 8 (1.3) | 2 (0.3) | 24 (4.0) | 2 (0.3) | 0 | 0 | 0 | 0 |
| n (%) . | Japanese subgroup . | Overall population . | ||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| . | AAP (n = 35) . | Placebo (n = 35) . | Placebo-AAP (n = 3) . | AAP (n = 597) . | Placebo (n = 602) . | Placebo-AAP (n = 72) . | ||||||||||||
| . | All grades . | Grade 3 . | Grade 4 . | All grades . | Grade 3 . | Grade 4 . | All grades . | Grade 3 . | Grade 4 . | All grades . | Grade 3 . | Grade 4 . | All grades . | Grade 3 . | Grade 4 . | All grades . | Grade 3 . | Grade 4 . |
| Mineralocorticoid-related AEs | ||||||||||||||||||
| Hypertension | 18 (51.4) | 12 (34.3) | 0 | 8 (22.9) | 2 (5.7) | 0 | 0 | 0 | 0 | 229 (38.4) | 125 (20.9) | 0 | 133 (22.1) | 59 (9.8) | 1 (0.2) | 4 (5.6) | 3 (4.2) | 0 |
| Hypokalemia | 15 (42.9) | 4 (11.4) | 1 (2.9) | 0 | 0 | 0 | 0 | 0 | 0 | 143 (24.0) | 65 (10.9) | 5 (0.8) | 23 (3.8) | 9 (1.5) | 1 (0.2) | 9 (12.5) | 2 (2.8) | 0 |
| Hepatotoxicity | 13 (37.1) | 3 (8.6) | 0 | 13 (37.1) | 1 (2.9) | 0 | 1 (33.3) | 1 (33.3) | 0 | 146 (24.5) | 49 (8.2) | 4 (0.7) | 109 (18.1) | 21 (3.5) | 0 | 7 (9.7) | 3 (4.2) | 0 |
| Cataract | 3 (8.6) | 2 (5.7) | 0 | 1 (2.9) | 1 (2.9) | 0 | 0 | 0 | 0 | 15 (2.5) | 8 (1.3) | 0 | 4 (0.7) | 1 (0.2) | 0 | 0 | 0 | 0 |
| Osteoporosis including osteoporosis-related fractures | 8 (22.9) | 1 (2.9) | 0 | 2 (5.7) | 0 | 0 | 0 | 0 | 0 | 43 (7.2) | 9 (1.5) | 0 | 27 (4.5) | 13 (2.2) | 1 (0.2) | 1 (1.4) | 0 | 0 |
| Fluid retention/oedema Cardiac | 1 (2.9) | 0 | 0 | 5 (14.3) | 0 | 0 | 0 | 0 | 0 | 81 (13.6) | 5 (0.8) | 0 | 71 (11.8) | 6 (1.0) | 0 | 3 (4.2) | 0 | 0 |
| Any | 4 (11.4) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 95 (15.9) | 18 (3.0) | 5 (0.8) | 52 (8.6) | 6 (1.0) | 0 | 1 (1.4) | 0 | 0 |
| Arrhythmia | 3 (8.6) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 49 (8.2) | 8 (1.3) | 2 (0.3) | 24 (4.0) | 2 (0.3) | 0 | 0 | 0 | 0 |
Grade 3 or 4 AEs of special interest in the Japanese subgroup versus the overall population (safety population)
| n (%) . | Japanese subgroup . | Overall population . | ||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| . | AAP (n = 35) . | Placebo (n = 35) . | Placebo-AAP (n = 3) . | AAP (n = 597) . | Placebo (n = 602) . | Placebo-AAP (n = 72) . | ||||||||||||
| . | All grades . | Grade 3 . | Grade 4 . | All grades . | Grade 3 . | Grade 4 . | All grades . | Grade 3 . | Grade 4 . | All grades . | Grade 3 . | Grade 4 . | All grades . | Grade 3 . | Grade 4 . | All grades . | Grade 3 . | Grade 4 . |
| Mineralocorticoid-related AEs | ||||||||||||||||||
| Hypertension | 18 (51.4) | 12 (34.3) | 0 | 8 (22.9) | 2 (5.7) | 0 | 0 | 0 | 0 | 229 (38.4) | 125 (20.9) | 0 | 133 (22.1) | 59 (9.8) | 1 (0.2) | 4 (5.6) | 3 (4.2) | 0 |
| Hypokalemia | 15 (42.9) | 4 (11.4) | 1 (2.9) | 0 | 0 | 0 | 0 | 0 | 0 | 143 (24.0) | 65 (10.9) | 5 (0.8) | 23 (3.8) | 9 (1.5) | 1 (0.2) | 9 (12.5) | 2 (2.8) | 0 |
| Hepatotoxicity | 13 (37.1) | 3 (8.6) | 0 | 13 (37.1) | 1 (2.9) | 0 | 1 (33.3) | 1 (33.3) | 0 | 146 (24.5) | 49 (8.2) | 4 (0.7) | 109 (18.1) | 21 (3.5) | 0 | 7 (9.7) | 3 (4.2) | 0 |
| Cataract | 3 (8.6) | 2 (5.7) | 0 | 1 (2.9) | 1 (2.9) | 0 | 0 | 0 | 0 | 15 (2.5) | 8 (1.3) | 0 | 4 (0.7) | 1 (0.2) | 0 | 0 | 0 | 0 |
| Osteoporosis including osteoporosis-related fractures | 8 (22.9) | 1 (2.9) | 0 | 2 (5.7) | 0 | 0 | 0 | 0 | 0 | 43 (7.2) | 9 (1.5) | 0 | 27 (4.5) | 13 (2.2) | 1 (0.2) | 1 (1.4) | 0 | 0 |
| Fluid retention/oedema Cardiac | 1 (2.9) | 0 | 0 | 5 (14.3) | 0 | 0 | 0 | 0 | 0 | 81 (13.6) | 5 (0.8) | 0 | 71 (11.8) | 6 (1.0) | 0 | 3 (4.2) | 0 | 0 |
| Any | 4 (11.4) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 95 (15.9) | 18 (3.0) | 5 (0.8) | 52 (8.6) | 6 (1.0) | 0 | 1 (1.4) | 0 | 0 |
| Arrhythmia | 3 (8.6) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 49 (8.2) | 8 (1.3) | 2 (0.3) | 24 (4.0) | 2 (0.3) | 0 | 0 | 0 | 0 |
| n (%) . | Japanese subgroup . | Overall population . | ||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| . | AAP (n = 35) . | Placebo (n = 35) . | Placebo-AAP (n = 3) . | AAP (n = 597) . | Placebo (n = 602) . | Placebo-AAP (n = 72) . | ||||||||||||
| . | All grades . | Grade 3 . | Grade 4 . | All grades . | Grade 3 . | Grade 4 . | All grades . | Grade 3 . | Grade 4 . | All grades . | Grade 3 . | Grade 4 . | All grades . | Grade 3 . | Grade 4 . | All grades . | Grade 3 . | Grade 4 . |
| Mineralocorticoid-related AEs | ||||||||||||||||||
| Hypertension | 18 (51.4) | 12 (34.3) | 0 | 8 (22.9) | 2 (5.7) | 0 | 0 | 0 | 0 | 229 (38.4) | 125 (20.9) | 0 | 133 (22.1) | 59 (9.8) | 1 (0.2) | 4 (5.6) | 3 (4.2) | 0 |
| Hypokalemia | 15 (42.9) | 4 (11.4) | 1 (2.9) | 0 | 0 | 0 | 0 | 0 | 0 | 143 (24.0) | 65 (10.9) | 5 (0.8) | 23 (3.8) | 9 (1.5) | 1 (0.2) | 9 (12.5) | 2 (2.8) | 0 |
| Hepatotoxicity | 13 (37.1) | 3 (8.6) | 0 | 13 (37.1) | 1 (2.9) | 0 | 1 (33.3) | 1 (33.3) | 0 | 146 (24.5) | 49 (8.2) | 4 (0.7) | 109 (18.1) | 21 (3.5) | 0 | 7 (9.7) | 3 (4.2) | 0 |
| Cataract | 3 (8.6) | 2 (5.7) | 0 | 1 (2.9) | 1 (2.9) | 0 | 0 | 0 | 0 | 15 (2.5) | 8 (1.3) | 0 | 4 (0.7) | 1 (0.2) | 0 | 0 | 0 | 0 |
| Osteoporosis including osteoporosis-related fractures | 8 (22.9) | 1 (2.9) | 0 | 2 (5.7) | 0 | 0 | 0 | 0 | 0 | 43 (7.2) | 9 (1.5) | 0 | 27 (4.5) | 13 (2.2) | 1 (0.2) | 1 (1.4) | 0 | 0 |
| Fluid retention/oedema Cardiac | 1 (2.9) | 0 | 0 | 5 (14.3) | 0 | 0 | 0 | 0 | 0 | 81 (13.6) | 5 (0.8) | 0 | 71 (11.8) | 6 (1.0) | 0 | 3 (4.2) | 0 | 0 |
| Any | 4 (11.4) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 95 (15.9) | 18 (3.0) | 5 (0.8) | 52 (8.6) | 6 (1.0) | 0 | 1 (1.4) | 0 | 0 |
| Arrhythmia | 3 (8.6) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 49 (8.2) | 8 (1.3) | 2 (0.3) | 24 (4.0) | 2 (0.3) | 0 | 0 | 0 | 0 |
This PDF is available to Subscribers Only
View Article Abstract & Purchase OptionsFor full access to this pdf, sign in to an existing account, or purchase an annual subscription.
