Treatment-emergent adverse reactions with IV administration once every 2 weeks (qow)
Incidence rates account for the different duration of exposure to MEPSEVII vs placeboa
n = number of reactions
aAdverse reactions occurred in one or more patients treated with MEPSEVII at a dosage of 4 mg/kg at a higher patient frequency than placebo.
bAdverse reaction incidence rates calculated per 8.3 patient years for exposure to MEPSEVII, and 2.7 years of exposure for placebo.
In the MEPSEVII safety study:
- 12 patients were enrolled, 4 were male and 8 were female
- Ages ranged from 8 to 25 years (median 14 years)
- Nine patients were younger than 18 years of age
- 1 patient treated with MEPSEVII experienced a febrile convulsion at week 66