TRAEs by Concomitant Mitotane Treatment (any grade in ≥10% of patients in either group or grade 3 in any patient)
| TRAE | With Mitotane (n = 25) | Without Mitotane (n = 25) | ||
|---|---|---|---|---|
| Any Grade | Grade 3 | Any Grade | Grade 3 | |
| Any TRAE, n (%) | 21 (84.0) | 6 (24.0) | 20 (80.0) | 2 (8.0) |
| Nausea | 7 (28.0) | 0 | 3 (12.0) | 0 |
| Fatigue | 5 (20.0) | 0 | 4 (16.0) | 0 |
| Pyrexia | 5 (20.0) | 0 | 2 (8.0) | 0 |
| ALT increased | 4 (16.0) | 2 (8.0) | 1 (4.0) | 0 |
| AST increased | 4 (16.0) | 1 (4.0) | 1 (4.0) | 0 |
| Asthenia | 3 (12.0) | 0 | 1 (4.0) | 0 |
| Back pain | 3 (12.0) | 0 | 0 | 0 |
| Chills | 3 (12.0) | 0 | 2 (8.0) | 0 |
| Diarrhea | 3 (12.0) | 0 | 2 (8.0) | 0 |
| Hypothyroidism | 3 (12.0) | 0 | 4 (16.0) | 0 |
| Adrenal insufficiency | 2 (8.0) | 1 (4.0) | 1 (4.0) | 0 |
| GGT increase | 2 (8.0) | 1 (4.0) | 0 | 0 |
| Vomiting | 2 (8.0) | 0 | 4 (16.0) | 0 |
| Anemia | 1 (4.0) | 1 (4.0) | 2 (8.0) | 0 |
| Hypophosphatemia | 1 (4.0) | 0 | 2 (8.0) | 1 (4.0) |
| Infusion-related reaction | 1 (4.0) | 0 | 4 (16.0) | 0 |
| Lymphopenia | 1 (4.0) | 1 (4.0) | 0 | 0 |
| Transaminases increased | 1 (4.0) | 1 (4.0) | 0 | 0 |
| Pneumonitis | 0 | 0 | 2 (8.0) | 1 (4.0) |
Abbreviations: ALT Alanine aminotransferase, AST Aspartate aminotransferase, GGT γ-glutamyltransferase