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