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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.