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Table 2 Comparison of adverse events overall and by severity

From: A phase 2, randomized, double-blind safety and pharmacokinetic assessment of respiratory syncytial virus (RSV) prophylaxis with motavizumab and palivizumab administered in the same season

  Mixed Motavizumab/Palivizumab (n = 83) Mixed Palivizumab/Motavizumab (n = 83) Motavizumab Only (n = 93)
Total number of AEs 405 408 459
Number (%) of children reporting:
   ≥1 AE 77 (92.8) 75 (90.4) 83 (89.2)
   ≥1 Level 1 AE, as the highest severity 17 (20.5) 26 (31.3) 22 (23.7)
   ≥1 Level 2 AE, as the highest severity 44 (53.0) 44 (53) 51 (54.8)
   ≥1 Level 3 AE, as the highest severity 13 (15.7) 5 (6.0) 6 (6.5)
   ≥1 Level 4 AE, as the highest severity 3 (3.6) 0 (0.0) 4 (4.3)
   ≥1 Related AE 14 (16.9) 16 (19.3) 21 (22.6)
   ≥1 SAE 19 (22.9)a 7 (8.4)a 11 (11.8)
   ≥1 Level 1 SAE, as the highest severity 1 (1.2) 0 (0.0) 0 (0.0)
   ≥1 Level 2 SAE, as the highest severity 4 (4.8) 4 (4.8) 4 (4.3)
   ≥1 Level 3 SAE, as the highest severity 11 (13.3)a 3 (3.6)a 4 (4.3)
   ≥1 Level 4 SAE, as the highest severity 3 (3.6) 0 (0.0) 3 (3.2)
   ≥1 Related SAE 2 (2.4) 0 (0.0) 1 (1.1)
   ≥1 AE resulting in discontinuation of study drug 3 (3.6) 0 (0.0) 0 (0.0)
   ≥1 Related AE resulting in discontinuation of study drug 2 (2.4) 0 (0.0) 0 (0.0)
   Death 2 (2.4) 0 (0.0) 1 (1.1)b
  1. a P < 0.05, mixed motavizumab/palivizumab vs. mixed palivizumab/motavizumab (2-sided Fisher's exact test; exploratory analysis only).
  2. bThis patient withdrew consent on study day 13 and died on study day 153.