Table 2.

AEs for dogs in the SRCBST study and mice treated with eBAT

A. Summary of AEs, including the empirical and model-based estimated rate by treatment group
Dose levelNAEsaAE rate – empirical (95% CI)AE Rate – from model (95% CI)
1 (25 μg/kg)300 (0–70.8)10.1 (0.3–31.9)
2 (50 μg/kg)17317.6 (3.8–43.4)19.5 (6.6–37.7)
3 (100 μg/kg)3266.7 (9.4–99.2)44.4 (10.3–90.6)
B. Description of AEs in individual dogs, management, and outcome
Dog ID and breedDose levelAEsManagementOutcome
MNb 112Grade 3 ALT elevation after 1st infusionSecond eBAT infusion delayed one weekFull recovery
Cairn TerrierHypotensive eventc during 2nd infusionIV fluid bolus 3rd eBAT infusion not administeredFull recovery
MN 17 Labrador retriever2Hypotensive event followed by a seizure during 1st infusionIV fluid bolus, infusion restated 45 minutes later with no complicationsFull recovery
MN 22 Rat terrier2Grade 2 ALT elevation after 1st infusionMonitoringFull recovery
MN 07 Newfoundland3Hypotensive event at the end of 3rd infusionIV fluid bolusFull recovery
MN 09 Goldendoodle3Hypotensive event during 2nd infusionIV fluid bolus, infusion not restartedFull recovery
C. Summary of death events in normal mice treated with ligand-specific toxins
Observed deaths (%)
TreatmentDose (μg/kg)
Monospecific EGF toxin0/8 (0)2/8 (25)6/8 (75)8/8 (100)8/8 (100)
Monospecific uPA toxin0/8 (0)0/8 (0)2/8 (25)8/8 (100)8/8 (100)
Monospecific EGF toxin + monospecific uPA toxin0/7 (0)1/7 (14)2/7 (29)7/7 (100)7/7 (100)
eBAT0/8 (0)0/8 (0)0/8 (0)0/8 (0)0/8 (0)
  • NOTE: Groups of 8 C57BL/6 mice were administered monospecific EGF toxin, monospecific uPA toxin, monospecific EGF toxin and monospecific uPA toxin, and eBAT intraperitoneally twice, 2 days apart, on days 1 and 3 and were subsequently monitored for the occurrence of AEs for 3 weeks.

  • Abbreviation: CI, confidence interval.

  • aTotal count of dogs experiencing AEs (not total number of AEs).

  • bMN = Minnesota (institutional assignment); dogs were coded using MN followed by a number assigned sequentially based on order of enrollment.

  • cHypotensive events noted in 4 dogs were characterized by mean arterial pressure <60 mm Hg, hind limb weakness, pale mucous membranes, weak femoral pulses, and a single vomiting episode in one dog. All other dogs had no AEs.