TABLE 2.

TEAEs associated with the single or dual infusion of anti-Stx antibody

Signs and symptomsaNo. (%) of subjects in the following treatment group
cαStx1 (1 mg/kg, n = 4)cαStx1 (3 mg/kg, n = 4)cαStx2 (1 mg/kg, n = 4)cαStx2 (3 mg/kg, n = 4)cαStx1/cαStx2 (1 mg/kg, n = 5)cαStx1/cαStx2 (3 mg/kg, n = 5)Total (n = 26)
Headache2000215 (19)
Somnolence0000415 (19)
Influenza, URTI,b pharyngitis2110004 (15)
Abdominal distension0000033 (12)
Muscle, skeletal, or joint pain1110003 (12)
Pyuria0001023 (12)
Dysuria, urinary tract infection0010102 (8)
Abdominal pain0000112 (8)
Nausea, vomiting0100012 (8)
Diarrhea0100012 (8)
Fever1100002 (8)
Irritation at intravenous catheter infusion site0000112 (8)
Irritation at intravenous catheter blood draw site0000202 (8)
Skin irritation, other0000011 (4)
Aphonia0010001 (4)
Breast pain1000001 (4)
Dizziness0100001 (4)
Hyperactivity0100001 (4)
Hypocalcemia0000011 (4)
Lymphadenopathy0000101 (4)
Microhematuria0001001 (4)
Neutrophilia0000011 (4)
Numbness0000011 (4)
Thrombocytosis1000001 (4)
  • a Signs and symptoms reported up to 14 days following the antibody infusion. Most adverse events were considered by the investigators and the Medical Safety Committee to be not related or only remotely related to the treatment (see text).

  • b URTI, upper respiratory tract infection.