Table 8. Adverse effects in proxalutamide and placebo groups in the South arm and in the North arm.
TEAE = Treatment emergent adverse effect; n/a = non-applicable; ALT = Alanine transferase
| Adverse effect | South Active N=106 Male (n=76) Female (n=30) | North Active N=317 Male (n=184) Female (n=133) | South Placebo N=27 Male (n=22) Female (n=5) | North Placebo N=328 Male (n=182) Female (n=146) | South between active versus placebo (p-value) | North between active versus placebo (p-value) | Active between regions (p-value) | Placebo between regions (p-value) |
| Number of subjects with 1 or more TEAE | 38 (35.8%) | 109 (34.4%) | 15 (55.5%) | 225 (68.6%) | 0.042 | <0.001 | 0.78 | 0.23 |
| Grade 5 – n (%) | ||||||||
| Death, Day 14 | 7 (6.6%) | 27 (8.5%) | 8 (29.6%) | 130 (39.6%) | 0.001 | <0.001 | 0.68 | 0.34 |
| Females | 7 (7.9%) | 11 (8.3%) | 6 (27.3%) | 53 (36.3%) | 0.03 | <0.001 | 0.22 | 1.00 |
| Males | 0 (0.0%) | 16 (8.7%) | 2 (40.0%) | 77 (42.3%) | 0.028 | <0.001 | 1.00 | 0.52 |
| Death, Day 28 | 10 (9.4%) | 35 (11.0%) | 9 (33.3%) | 162 (49.4%) | 0.002 | <0.001 | 0.72 | 0.11 |
| Females | 8 (10.5%) | 12 (9.0%) | 7 (31.8%) | 71 (48.6%) | 0.016 | <0.001 | 1.00 | 1.00 |
| Males | 2 (6.7%) | 23 (12.5%) | 2 (40.0%) | 91 (50.0%) | 0.041 | <0.001 | 0.83 | 0.12 |
| Grades 4 or 3 – n (%) | ||||||||
| Shock, requiring vasopressors | 12 (11.3%) | 37 (11.7%) | 10 (37.0%) | 168 (51.2%) | 0.001 | <0.001 | 0.92 | 0.21 |
| Mechanical ventilation, Day 14 | 3 (2.8%) | 4 (1.3%) | 4 (14.8%) | 37 (11.3%) | 0.024 | 0.038 | 0.29 | 0.58 |
| Females | 2 (6.7%) | 1 (0.8%) | 1 (20.0%) | 20 (13.7%) | 0.42 | 0.089 | 0.071 | 0.83 |
| Males | 1 (1.3%) | 3 (1.6%) | 3 (13.6%) | 17 (9.3%) | 0.038 | 0.28 | 0.85 | 0.52 |
| Mechanical ventilation, Day 28 | 0 | 5 (1.6%) | 2 (7.4%) | 41 (12.5%) | 0.055 | <0.001 | 0.37 | 0.71 |
| Females | 0 | 1 (0.8%) | 0 | 22 (15.1%) | n/a | <0.001 | 0.82 | 0.66 |
| Males | 0 | 4 (2.2%) | 2 (9.1%) | 19 (10.4%) | 0.066 | 0.001 | 0.37 | 0.85 |
| Disease progression | 17 (16.0%) | 36 (11.4%) | 14 (51.9%) | 168 (51.2%) | 0.0001 | <0.001 | 0.20 | 0.95 |
| Females | 3 (10.0%) | 12 (9.0%) | 4 (80.0%) | 74 (50.7%) | 0.0009 | <0.001 | 0.87 | 0.055 |
| Males | 14 (18.4%) | 24 (13.0%) | 10 (45.5%) | 94 (51.6%) | 0.007 | <0.001 | 0.26 | 0.60 |
| Renal failure (creatinine increase > 100%) | 1 (0.9%) | 5 (1.6%) | 2 (7.4%) | 21 (6.4%) | 0.087 | 0.29 | 1.00 | 0.69 |
| Females | 0 (0.0%) | 1 (0.8%) | 0 (0.0%) | 11 (7.5%) | n/a | 0.33 | 1.00 | 1.00 |
| Males | 1 (1.3%) | 4 (2.2%) | 2 (9.1%) | 10 (5.5%) | 0.11 | 0.58 | 1.00 | 0.62 |
| Liver damage (ALT > 250 U/L or >100% increase) | 4 (3.8%) | 4 (1.3%) | 3 (11.1%) | 19 (5.8%) | 0.14 | 0.32 | 0.11 | 0.23 |
| Females | 1 (3.3%) | 0 (0.0%) | 0 (0.0%) | 10 (6.8%) | 0.73 | 0.37 | 0.18 | 1.00 |
| Males | 3 (3.9%) | 4 (2.2%) | 3 (13.6%) | 9 (4.9%) | 0.11 | 0.65 | 0.42 | 0.20 |
| Grades 2 or 1 – n (%) | ||||||||
| Diarrhea | 26 (24.5%) | 51 (16.1%) | 1 (3.7%) | 11 (3.4%) | 0.058 | 0.005 | 0.059 | 1.00 |
| Females | 7 (23.3%) | 22 (16.5%) | 0 (0.0%) | 7 (4.8%) | 0.44 | 0.091 | 0.43 | 1.00 |
| Males | 19 (25.0%) | 29 (15.8%) | 1 (4.5%) | 4 (2.2%) | 0.087 | 0.025 | 0.11 | 0.44 |
| Abdominal pain | 2 (1.9%) | 3 (0.9%) | 1 (3.7%) | 1 (0.3%) | 0.58 | 0.89 | 0.60 | 0.15 |
| Females | 0 (0.0%) | 1 (0.8%) | 0 (0.0%) | 0 (0.0%) | n/a | 0.91 | 1.00 | n/a |
| Males | 2 (2.6%) | 2 (1.1%) | 1 (4.5%) | 1 (0.5%) | 0.65 | 0.93 | 0.58 | 0.20 |
| Irritability | 5 (4.7%) | 4 (1.3%) | 0 (0.0%) | 0 (0.0%) | 0.47 | 0.78 | 0.048 | n/a |
| Females | 0 (0.0%) | 1 (0.8%) | 0 (0.0%) | 0 (0.0%) | n/a | 0.91 | 1.00 | n/a |
| Males | 5 (6.6%) | 3 (1.6%) | 0 (0.0%) | 0 (0.0%) | 0.41 | 0.79 | 0.049 | n/a |
| Spontaneous erection (Males) | 3 (3.9%) | 4 (2.2%) | 0 (0.0%) | 0 (0.0%) | 0.62 | 0.73 | 0.42 | n/a |
| Vomiting, dyspepsia, or palpitations | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | n/a | n/a | n/a | n/a |