Table 3.
Summary of treatment emergent adverse events (TEAEs).
| Characteristic |
Proxalutamide N = 134 |
Placebo N = 128 |
P |
|---|---|---|---|
| 1 or more TEAE, no. (%) | 82 (61.2%) | 116 (90.6%) | |
| General, no. (%) | |||
| Disease progression | 4 (3) | 43 (34) | <0.001 |
| Hypoxemia (>4% decrease or reaching SpO2 <92%) | 3 (2) | 36 (28) | <0.001 |
| Tachycardia | 6 (4) | 45 (35) | <0.001 |
| Fatigue | 1 (1) | 71 (55) | <0.001 |
| Shortness of breath | 4 (3) | 40 (31) | <0.001 |
| Fever | 2 (1) | 34 (27) | <0.001 |
| Dehydration | 20 (15) | 51 (39) | <0.001 |
| Increase in ALT or AST (over the ULN) | 4 (3) | 22 (17) | <0.001 |
| Gastrointestinal, no. (%) | |||
| Diarrhea | 39 (28) | 20 (16) | 0.009 |
| Dyspepsia or heartburn | 23 (17) | 6 (5) | 0.001 |
| Abdominal pain or discomfort | 22 (16) | 18 (14) | 0.596 |
| Nausea | 21 (16) | 15 (12) | 0.353 |
| Vomiting | 4 (3) | 6 (5) | 0.472 |
| Nervous system, no. (%) | |||
| Headache | 1 (1) | 12 (9) | 0.001 |
| Ageusia | 13 (10) | 23 (18) | 0.052 |
| Anosmia | 14 (10) | 26 (20) | 0.026 |
| Diffuse sweating | 48 (36) | 5 (4) | <0.001 |
| Orthostatic dizziness | 6 (4) | 8 (6) | 0.524 |
| Musculoskeletal, no. (%) | |||
| Arthralgia | 5 (4) | 22 (17) | <0.001 |
| Muscle pain | 3 (2) | 39 (30) | <0.001 |
| Lower back pain | 11 (8) | 24 (19) | 0.012 |
| Upper back pain | 5 (4) | 12 (9) | 0.064 |
| Pain in extremity | 2 (1) | 4 (3) | 0.377 |
| Skin and subcutaneous tissue, no. (%) | |||
| Skin Lesions | 10 (7) | 7 (5) | 0.512 |
| Total TEAE, no.* | 276 | 591 | – |
*Patients with multiple adverse events were counted more than once in the total TEAEs.
ALT, alanine aminotransferase; AST, aspartate aminotransferase; ULN, Upper Limit of Normality.