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Table 4 Adverse events

From: Canakinumab (ACZ885, a fully human IgG1 anti-IL-1β mAb) induces sustained remission in pediatric patients with cryopyrin-associated periodic syndrome (CAPS)

Patients with AEs and SAEs

n (%)

SAEs*

1 (14)

AEs leading to study drug discontinuation

1**

AEs reported in ≥2 patients

 

   Upper respiratory tract infection

5 (71)

   Rash

4 (57)

   Pharyngitis

3 (43)

   Nasopharyngitis

3 (43)

   Vomiting

3 (43)

   Diarrhea

2 (29)

   Rhinitis

2 (29)

   Sleep disorder

2 (29)

   Cough

2 (29)

   Pharyngolaryngeal pain

2 (29)

   Acne

2 (29)

  1. *One patient experienced vertigo, considered as a SAE, which resolved during treatment. ** pregnancy