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Table 4 Overview of safety data before and after dose 3

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

  Before Dose 3 After Dose 3
  Mixed Motavizumab/Palivizumab (n = 83) Mixed Palivizumab/Motavizumab (n = 83) Motavizumab Only (n = 93) Mixed Motavizumab/Palivizumab (n = 78a) Mixed Palivizumab/Motavizumab (n = 82a) Motavizumab Only (n = 92a)
AEs, n 175 186 204 230 222 255
Subjects reporting, n (%)       
   ≥1 AE 66 (79.5) 64 (77.1) 69 (74.2) 70 (89.7) 68 (82.9) 71 (77.2)
   ≥1 Level 3 AE as highest severity 3 (3.6) 3 (3.6) 1 (1.1) 10 (12.8) 3 (3.7) 5 (5.4)
   ≥1 Level 4 AE 3 (3.6)b 0 (0.0) 1 (1.1) 0 (0.0) 0 (0.0) 3 (3.3)b
   ≥1 Related AE 13 (15.7) 9 (10.8) 13 (14.0) 6 (7.7) 11 (13.4) 15 (16.3)
   ≥1 SAE 10 (12.0) 4 (4.8) 6 (6.5) 12 (15.4) 5 (6.1) 6 (6.5)
   ≥1 Related SAE 2 (2.4) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 (1.1)
   ≥1 AE resulting in discontinuation of study drug 2 (2.4)c 0 (0.0) 0 (0.0) 1 (1.3) 0 (0.0) 0 (0.0)
   Death 2 (2.4) 0 (0.0) 1 (1.1)d 0 (0.0) 0 (0.0) 0 (0.0)
  1. aThe total number of subjects who received at least 3 doses of study drug.
  2. bNone of the subjects who reported a level 4 AE had a level 3 AE.
  3. cIncludes 1 subject with an SAE of visual disturbance who discontinued after 1 dose (followed to the end of the study period by an ophthalmologist, but did not complete the study follow-up) and 1 subject with an SAE of erythema multiforme who discontinued after 2 doses (followed to the end of the study period and completed the study follow-up). A third subject experienced staphylococcal scalded skin syndrome after receiving 3 doses and also completed the study follow-up. All 3 subjects are included in the safety population.
  4. dThis subject withdrew consent on study day 13 and died on study day 153.