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Clinical Review Report: abobotulinumtoxinA (Dysport Therapeutic): (Ipsen Biopharmaceuticals Canada Inc.): Indication: For the symptomatic treatment of lower-limb spasticity in pediatric patients 2 years of age and older [Internet]. Ottawa (ON): Canadian Agency for Drugs and Technologies in Health; 2018 Aug.

Cover of Clinical Review Report: abobotulinumtoxinA (Dysport Therapeutic)

Clinical Review Report: abobotulinumtoxinA (Dysport Therapeutic): (Ipsen Biopharmaceuticals Canada Inc.): Indication: For the symptomatic treatment of lower-limb spasticity in pediatric patients 2 years of age and older [Internet].

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Table 15Harms (Dose per Leg) for Study 141 — Safety Population

AboBoNTA 10 U/kg/leg

(N = 80)

AboBoNTA 15 U/kg/leg

(N = 80)

Placebo

(N = 79)

Patients with > 0 TEAE, N (%)
Most common TEAEs,a N (%)
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Patients with > 0 SAEs, N (%)
Most common SAEs, N (%)
 ▬
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WDAEs, N (%)
Number of deaths, N (%)
Notable harms, N (%)
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aboBoNTA = abobotulinumtoxinA; SAE = serious adverse event; TEAE = treatment-emergent adverse event; WDAE = withdrawal due to adverse event.

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Source: Study 141 Clinical Study Report.22

From: Results

Copyright © 2018 Canadian Agency for Drugs and Technologies in Health.

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