Table 4 Frequency of patients with treatment emergent adverse events of at least CTCAE grade III in at least 10% of patients by System Organ Class and Preferred Term (MedDRA 20.0).
CTCAE System Organ Class CTCAE Term | Treosulfan (N = 65) |
|---|---|
Subjects with any event | 50 (76.9%) |
Gastrointestinal disorders | |
Any event | 37 (56.9%) |
Mucositis—oral | 28 (43.1%) |
Nausea | 11 (16.9%) |
Vomiting | 11 (16.9%) |
Diarrhea | 10 (15.4%) |
Dysphagia | 2 (3.1%) |
Abdominal pain | 1 (1.5%) |
Esophageal pain | 1 (1.5%) |
Typhlitis | 1 (1.5%) |
Upper gastrointestinal hemorrhage | 1 (1.5%) |
Infections and infestations | |
Any event | 28 (43.1%) |
Infections and infestations—other, specify | 20 (30.8%) |
Catheter-related infection | 6 (9.2%) |
Sepsis | 4 (6.2%) |
Bladder infection | 3 (4.6%) |
Urinary tract infection | 3 (4.6%) |
Encephalitis infection | 1 (1.5%) |
Hepatitis viral | 1 (1.5%) |
Laryngitis | 1 (1.5%) |
Skin infection | 1 (1.5%) |
Soft tissue infection | 1 (1.5%) |
Upper respiratory infection | 1 (1.5%) |
