Table 2 Adverse events.
Grade 3/4 AEs | Arm A, N = 16 (%) | Arm B, N = 45 (%) |
|---|---|---|
Adrenal insufficiency | 0 (0.0) | 1 (2.2) |
ALT increase | 0 (0.0) | 2 (4.40 |
Anemia | 2 (12.5) | 8 (17.8) |
Anorectal infection | 0 (0.0) | 1 (2.2) |
Arthralgia | 1 (6.3) | 0 (0.0) |
AST increase | 0 (0.0) | 1 (2.2) |
Diarrhea | 0 (0.0) | 1 (2.2) |
Gastroesophageal reflux disease | 0 (0.0) | 1 (2.2) |
Glucose intolerance | 0 (0.0) | 1 (2.2) |
Eye inflammation | 1 (6.3) | 0 (0.0) |
Hypocalcemia | 1 (6.3) | 0 (0.0) |
Hypokalemia | 0 (0.0) | 1 (2.2) |
Hypertension | 0 (0.0) | 1 (2.2) |
Nausea | 0 (0.0) | 1 (2.2) |
Neutropenia | 7 (43.8) | 15 (33.3) |
Thrombocytopenia | 1 (6.3) | 0 (0.0) |
Rash | 2 (12.6) | 1 (2.2) |
Scleral disorder | 0 (0.0) | 1 (2.2) |
Sepsis | 0 (0.0) | 1 (2.2) |
Skin abscess | 0 (0.0) | 2 (4.4) |
Syncope | 1 (6.3) | 1 (2.2) |
Vomiting | 0 (0.0) | 1 (2.2) |
Leucopenia | 0 (0.0) | 1 (2.2) |
Patients with any SAEs | 4 (25.0) | 10 (22.2) |
SAEs | ||
ALT increase | 0 (0.0) | 1 (2.2) |
Anemia | 0 (0.0) | 1 (2.2) |
Anorectal infection | 0 (0.0) | 1 (2.2) |
Arthralgia | 1 (6.3) | 1 (2.2) |
AST increase | 0 (0.0) | 1 (2.2) |
Diarrhea | 0 (0.0) | 1 (2.2) |
Eye inflammation | 1 (6.3) | 1 (2.2) |
Fatigue | 0 (0.0) | 1 (2.2) |
Febrile neutropenia | 0 (0.0) | 1 (2.2) |
Fever | 0 (0.0) | 1 (2.2) |
Fracture | 0 (0.0) | 1 (2.2) |
Hyperglycemia | 0 (0.0) | 1 (2.2) |
Hypocalcemia | 1 (6.3) | 1 (2.2) |
Nausea | 0 (0.0) | 1 (2.2) |
Neutropenia | 1 (6.3) | 2 (4.4) |
Rash | 0 (0.0) | 1 (2.2) |
Sepsis | 0 (0.0) | 1 (2.2) |
Syncope | 0 (0.0) | 2 (4.4) |
Ventricular tachycardia | 0 (0.0) | 1 (2.2) |
Vomiting | 0 (0.0) | 1 (2.2) |
