Table 3.

Summary of the most common adverse events (≥10% of Palladia-treated dogs) during blinded phase

Adverse eventPlacebo (n = 64)
Palladia (n = 87)
P*
Any grade, n (%)Grade 3 or 4, n (%)Any grade, n (%)Grade 3 or 4, n (%)Any grade, n (%)Grade 3 or 4, n (%)
Any10 (15.6)18 (20.7)0.527
Gastrointestinal
    Diarrhea17 (26.6)2 (3.1)40 (46.0)6 (6.9)0.0180.468
    Emesis21 (32.8)4 (6.3)28 (32.2)8 (9.2)1.0000.560
    Blood in stool, gastrointestinal bleed, hemorrhagic diarrhea2 (3.1)0 (0.0)11 (12.6)2 (2.3)0.044
Systemic disorder
    Anorexia, including decreased appetite20 (31.3)4 (6.3)34 (39.1)6 (6.9)0.3911.000
    Lethargy19 (29.7)2 (3.1)31 (35.6)4 (4.6)0.4870.703
    Weight loss2 (3.1)0 (0.0)13 (14.9)1 (1.1)0.025
Musculoskeletal
    Lameness6 (9.4)0 (0.0)15 (17.2)0 (0.0)0.234
    Musculoskeletal disorder not otherwise specified4 (6.3)0 (0.0)10 (11.5)1 (1.1)0.396
Laboratory abnormality
Hematology
    Neutrophils4 (6.3)0 (0.0)40 (46.0)0 (0.0)<0.0001
    Platelets13 (20.3)0 (0.0)21 (24.1)0 (0.0)0.694
Serum Chemistry
    ALT14 (21.9)3 (4.7)21 (24.1)1 (1.1)0.846
    Albumin5 (7.8)0 (0.0)11 (12.6)0 (0.0)0.428
  • NOTE: Canine-Adapted Common Toxicity Criteria; see Supplemental Table S2. Adverse events not listed in Supplemental Table S2 were assigned grades of 1, 2, 3, or 4 for mild, moderate, severe, or life-threatening, respectively.

  • Adverse events reported by investigators were coded using terms provided by the Committee for Medicinal Products for Veterinary Use Veterinary Dictionary for Drug Regulatory Activities (CVMP VEDDRA Version 2.0; 18OCT04) in order to facilitate summarization of data.

  • Abbreviation: ALT, alanine aminotransferase.

  • * P value (Pearson χ2) was calculated when at least 5 adverse events occurred. Grade 4 adverse events in dogs on placebo included emesis (3.1%), anorexia (1.6%), and ALT (1.6%). Grade 4 adverse events in dogs on Palladia included diarrhea (3.4%), emesis (2.3%), anorexia (1.1%), lethargy (1.1%), and ALT (1.1%).