Table 3.
Profile of adverse event, any attribution, of severity grade 3+ or occurring in more than 30% of patients.
| Number of Patients with AEs by ALT-801 Dose Level | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Organ-System | 0.015 mg/kg (n of 4) | 0.040 mg/kg (n of 16) | 0.080 mg/kg (n of 6) | All AEs | ||||||||||
|
|
|
|
|
|||||||||||
| - CTCAE Term Grade | 1 | 2 | 3 | 4 | 1 | 2 | 3 | 4 | 1 | 2 | 3 | 4 | n | (%) |
| Constitutional | ||||||||||||||
| - Fever | 1 | 3 | 0 | 0 | 3 | 9 | 4 | 0 | 0 | 5 | 1 | 0 | 26 | (100%) |
| - Rigors/chills | 0 | 2 | 0 | 0 | 2 | 12 | 0 | 0 | 1 | 4 | 1 | 0 | 22 | (85%) |
| - Fatigue | 1 | 1 | 0 | 0 | 4 | 2 | 3 | 0 | 0 | 0 | 0 | 0 | 11 | (42%) |
| Gastrointestinal | ||||||||||||||
| - Nausea | 1 | 0 | 0 | 0 | 7 | 3 | 0 | 0 | 3 | 0 | 0 | 0 | 14 | (54%) |
| - Vomiting | 0 | 1 | 0 | 0 | 9 | 1 | 0 | 0 | 1 | 0 | 0 | 0 | 12 | (46%) |
| - Diarrhea | 0 | 0 | 0 | 0 | 5 | 1 | 0 | 0 | 2 | 0 | 0 | 0 | 8 | (31%) |
| Blood | ||||||||||||||
| - Thormbocytopenia | 3 | 0 | 0 | 0 | 4 | 5 | 0 | 1 | 0 | 4 | 0 | 1 | 18 | (69%) |
| - Anemia | 1 | 1 | 0 | 0 | 4 | 6 | 2 | 0 | 0 | 3 | 0 | 0 | 17 | (65%) |
| - Lymphopenia | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 6 | 0 | 0 | 1 | 1 | 9 | (35%) |
| Cardiac/Vascular | ||||||||||||||
| - Hypotension | 1 | 1 | 0 | 0 | 1 | 7 | 1 | 0 | 1 | 2 | 2 | 0 | 16 | (62%) |
| - Supraventricular/sinus tachycardia | 0 | 0 | 0 | 0 | 7 | 1 | 0 | 0 | 0 | 2 | 1 | 0 | 11 | (42%) |
| - Cardiac ischemia/infarction | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 2 | (8%) |
| - Thrombosis/embolism | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 1 | 0 | 2 | (8%) |
| - Elevated c-troponin I | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 | (4%) |
| Hepatic | ||||||||||||||
| - Elevated alkaline phosphatase | 1 | 0 | 0 | 0 | 5 | 1 | 0 | 0 | 3 | 0 | 0 | 0 | 10 | (38%) |
| - Elevated bilirubin | 0 | 1 | 0 | 0 | 0 | 3 | 1 | 0 | 0 | 2 | 0 | 0 | 7 | (27%) |
| Pulmonary | ||||||||||||||
| - Hypoxia | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 3 | (12%) |
| - Pleural effusion | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 1 | (4%) |
| - Pneumonitis | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 | (4%) |
| Renal | ||||||||||||||
| - Hypoalbuminemia | 1 | 2 | 0 | 0 | 2 | 11 | 3 | 0 | 0 | 4 | 2 | 0 | 25 | (96%) |
| - Decreased urine output | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 1 | 1 | 0 | 3 | (12%) |
| Skin | ||||||||||||||
| - Pruritus | 0 | 0 | 0 | 0 | 3 | 6 | 0 | 0 | 1 | 3 | 0 | 0 | 13 | (50%) |
| - Rash/desquamation | 0 | 2 | 0 | 0 | 3 | 4 | 1 | 0 | 1 | 1 | 0 | 0 | 12 | (46%) |
| Pain | ||||||||||||||
| - Musculoskeletal | 0 | 1 | 0 | 0 | 3 | 1 | 0 | 0 | 3 | 0 | 0 | 0 | 8 | (31%) |
| - Pulmonary | 1 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 2 | (8%) |
| - Chest | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 | (4%) |
| - General | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 1 | (4%) |
| Metabolic | ||||||||||||||
| - Hypophosphatemia | 0 | 0 | 2 | 0 | 1 | 5 | 8 | 1 | 0 | 0 | 4 | 0 | 21 | (81%) |
| - Hypocalcemia | 0 | 3 | 0 | 0 | 3 | 8 | 1 | 0 | 2 | 2 | 1 | 0 | 20 | (77%) |
| - Hyponatremia | 0 | 0 | 2 | 0 | 11 | 0 | 2 | 0 | 4 | 0 | 0 | 0 | 19 | (73%) |
| - Hypokalemia | 1 | 1 | 0 | 0 | 7 | 0 | 1 | 0 | 1 | 0 | 0 | 0 | 11 | (42%) |
| - Hypomagnesemia | 1 | 0 | 0 | 0 | 6 | 0 | 0 | 0 | 4 | 0 | 0 | 0 | 11 | (42%) |
| - Hyperglycemia | 0 | 0 | 0 | 0 | 4 | 0 | 1 | 0 | 1 | 0 | 0 | 0 | 6 | (23%) |
| - Hyperkalemia | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 3 | (12%) |