TABLE 3.

Detailed analysis of TEAEs associated with anti-Stx antibody infusiona

TreatmentTEAENo. of volunteers with symptomsSubject no.Onset (time after infusionc)Severityb
cαStx1 (1 mg/kg)Thrombocytosis137 daysMild
Influenza (URTI,d pharyngitis, cough)1310 daysMild
Back pain1311 daysMild
Headache, chills1313 daysMild
Fever1314 daysModerate
Breast pain146 daysModerate
Headache1411 daysModerate
URTI (sore throat)1412 daysMild
cαStx1 (3 mg/kg)Influenza (fever, dizziness, muscle or joint pain, conjunctivitis)1510 daysMild/moderate
Nausea, vomiting1510 daysModerate/mild
Diarrhea1511 daysModerate
Hyperactivity184 daysMild
cαStx2 (1 mg/kg)Urinary tract infection (twice)193 days, 14 daysMild
Aphonia1123 daysModerate
Influenza (pharyngitis, arthralgia)11213 daysMild
cαStx2 (3 mg/kg)Microhematuria1133 daysMild
Pyuria1153 daysMild
cαStx1 and cαStx2 (1 mg/kg each)Somnolence41770 minModerate
1860 minMild
19−100 min, 72 minMild/moderate
20−44 minModerate
Headache2175 hMild
18−1 hMild
Irritation IV catheter blood draw site21921 hMild
20−2 hMild
Irritation at intravenous catheter infusion site120−2 hMild
Abdominal pain1206 hModerate
Lymphadenopathy (inguinal)11812 daysMild
Dysuria1213 daysMild
cαStx1 and cαStx2 (3 mg/kg each)Abdominal distention1225 hModerate
Abdominal distention1256.5 hMild
Abdominal distention12611 hMild
Diarrhea, abdominal pain1225 hMild
Nausea1232.5 hMild
Headache123−19 min, 3 hMild/moderate
Somnolence123−19 min, 45 minMild/moderate
Irritation at intravenous catheter (infusion site)124−80 minMild
Skin irritation (other)1264.5 daysMild
Numbness (occipital)125During infusionMild
Pyuria22522 hModerate
2614 daysMild
Neutrophilia1253 daysMild
Hypocalcemia1257 daysMild
  • a Most signs and symptoms were considered not related or only remotely related to the antibody infusion.

  • b All signs and symptoms resolved without complications or specific therapy.

  • c Negative values denote events reported prior to the begin of the infusion of the investigational product.

  • d URTI, upper respiratory tract infection.