Table 4.

Incidence of common adverse events in dogs with naturally occurring non-Hodgkin's lymphoma treated with GS-9219 monotherapy with different dosing schedules

Adverse event and gradeDose and regimen
Daily × 5 d every 21 d
Once every 7 dOnce every 14 d
Once every 21 d
0.20 mg/kg (n = 7)0.29 mg/kg (n = 6)0.66 mg/kg (n = 3)0.82 mg/kg (n = 6)0.66 mg/kg (n = 3)0.82 mg/kg (n = 6)0.66 mg/kg (n = 3)0.82 mg/kg (n = 4)
Anorexia
    13214222
    211
    3111
Emesis
    1321
    211
Nausea
    122
    41
Diarrhea
    1231331
    2111
    31
Weight loss
    111311
    222
Lethargy
    16431
    2111
    41
Neutropenia
    1111
    221
    311
    41
Dermatopathy*
    11212
    2121
    31111
Hyperbilirubinemia
    11121
    21112
    3113
Glucosuria
    11111
    21
Proteinuria
    11122
    21
  • NOTE: Incidence is number of dogs with adverse event; if event was observed more than once, only the greatest severity event is listed.

  • * Dermatopathy consisted most commonly of focal otitis externa or focal erythemic skin lesions in the ventrum. Four dogs developed grade 3 skin lesions that resulted in a delay in treatment in two of the dogs; these lesions resolved with symptomatic treatment in each animal.

  • Hyperblirubinemia noted was transient and spurious in nature, as a correlation to the timing of GS-9219 administration was not consistent, and in nearly all instances, values were normal at time points both just preceding and following the noted change.