Table 1.

Treatment-related adverse events occurring at or within 48 hours of ADXS31-164 vaccination

Number of dogs with treatment-related adverse events
ADXS31-164 dose (CFU)2 × 1085 × 1081 × 1093.3 × 109Total
GradeParametersn = 3n = 3n = 12n = 523
General disorders
 Pyrexia1103.5–104°F11114
2>104–105.8°F00033
 Vomiting1<3 episodes in 24 hours
23–10 episodes in 24 hours00101
Cardiovascular abnormalities
 Arrhythmias1Asymptomatic02a114
2Nonurgent intervention0001a1
 Tachycardia1Asymptomatic10203
 Hypotension00000
 Hypertension1Systolic ≥160 mm Hg239519
Hematologic parameters
 Thrombocytopenia1100,000/μL to <LLN327113
250,000−99,000/μL00202
Biochemical parameters (increased)
 γ-GT00101
 ALKP1>ULN to 2.5x ULN01528
2>2.5 to 5x ULN10001
 ALT1>ULN to 1.5x ULN00303
2>1.5 to 4x ULN10012
 AST1>ULN to 1.5x ULN11327
2>1.5 to 2x ULN00202
3>2.0 to 10x ULN00101
Cardiac Troponin I>0.2 μg/L00101
  • NOTE: To eliminate bias in recording adverse events in dogs with a favorable outcome, adverse events that occurred only during the initial 1 to 3 treatments for all 23 dogs are reported. Two dogs with preexisting metastatic disease and elevations in cTnI at baseline showed a reduction in cTnI after vaccination, although levels did not return to normal. These dogs are not included in this table. The asterisk denotes two exceptions to this with a ventricular tachycardia and grade II, accelerated idioventricular rhythmn occurring at repeat administration of ADXS31-164 in 2 dogs.

  • Abbreviations: LLN, lower limit of normal; ULN, upper limit of normal.

  • aSeen at repeat ADXS31-164 administration after initial series.