Skip to main content

Table 3 Summary of TEAEs (all causalities and treatment related) by treatment in order of frequency

From: Response to Tetanus and Pneumococcal Vaccination Following Administration of Ixekizumab in Healthy Participants

MedDRA preferred term All causalities TEAE
#AE [#subjects reporting AE]
Treatment-related TEAE
#AE [#subjects reporting AE]
Controla
(N = 42)
IXEb
(N = 41)
Controla
(N = 42)
IXEb
(N = 41)
Headache 2 [2] 2 [2] 1 [1] 1 [1]
Injection site erythema   4 [2]   4 [2]
Fatigue 1 [1] 2 [2]   2 [2]
Lymph node pain 1 [1] 1 [1] 1 [1] 1 [1]
Diarrhea 1 [1] 1 [1]   1 [1]
Nausea   2 [2]   2 [2]
Back pain   2 [2]   1 [1]
Oropharyngeal pain   2 [2]   1 [1]
Injection site pruritus   2 [1]   2 [1]
Joint swelling   2 [1]   
Abdominal tenderness   1 [1]   1 [1]
Dry mouth   1 [1]   
Vomiting   1 [1]   1 [1]
Chills   1 [1]   1 [1]
Influenza like illness 1 [1]   1 [1]  
Injection site discoloration   1 [1]   1 [1]
Mass   1 [1]   
Vulvovaginal candidiasisc   1 [1]   1 [1]
Neck pain   1 [1]   
Dizziness   1 [1]   1 [1]
Aggression   1 [1]   
Anxiety 1 [1]    
Depression   1 [1]   
Insomnia 1 [1]    
Throat irritation 1 [1]    
  1. Data presented as number of AEs [number of subjects with AEs]
  2. AE adverse event, IXE ixekizumab, MedDRA Medical Dictionary for Regulatory Activities, N number of subjects randomized, TEAE treatment emergent adverse event
  3. aControl arm = vaccine
  4. bIXE arm = IXE + vaccine
  5. cGender-specific event for females (N = 19 in the IXE group)