Table 4.

Profile of AE, any attribution, of severity grade 3+ or occurring in more than 30% of patients

Organ-system-CTCAE term gradeNumber of patients with AEs by ALT-801 dose level
0.015 mg/kg (n of 4)0.040 mg/kg (n of 16)0.080 mg/kg (n of 6)All AEs
123412341234n (%)
Constitutional
 Fever13003940051026 (100)
 Rigors/chills020021200141022 (85)
 Fatigue11004230000011 (42)
Gastrointestinal
 Nausea10007300300014 (54)
 Vomiting01009100100012 (46)
 Diarrhea0000510020008 (31)
Blood
 Thormbocytopenia30004501040118 (69)
 Anemia11004620030017 (65)
 Lymphopenia0000001600119 (35)
Cardiac/vascular
 Hypotension11001710122016 (62)
 Supraventricular/sinus tachycardia00007100021011 (42)
 Cardiac ischemia/infarction0000000001012 (8)
 Thrombosis/embolism0000010000102 (8)
 Elevated c-troponin I0000000000101 (4)
Hepatic
 Elevated alkaline phosphatase10005100300010 (38)
 Elevated bilirubin0100031002007 (27)
Pulmonary
 Hypoxia0100000000203 (12)
 Pleural effusion0000000100001 (4)
 Pneumonitis0000000000101 (4)
Renal
 Hypoalbuminemia120021130042025 (96)
 Decreased urine output0000001001103 (12)
Skin
 Pruritus00003600130013 (50)
 Rash/desquamation02003410110012 (46)
Pain
 Musculoskeletal0100310030008 (31)
 Pulmonary1000001000002 (8)
 Chest0000000000101 (4)
 General0000001000001 (4)
Metabolic
 Hypophosphatemia00201581004021 (81)
 Hypocalcemia03003810221020 (77)
 Hyponatremia002011020400019 (73)
 Hypokalemia11007010100011 (42)
 Hypomagnesemia10006000400011 (42)
 Hyperglycemia0000401010006 (23)
 Hyperkalemia0000200000103 (12)