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Table 3 Adverse events occurring at ≥5% of any treatment group at any severity level

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 subjects reporting1 AE 77 (92.8) 75 (90.4) 83 (89.2)
Number (%) of subjects reporting AE by body system a
Blood and lymphatic system disorders
   Anaemia 2 (2.4) 6 (7.2) 3 (3.2)
Eye disorders
   Conjunctivitis 6 (7.2) 11 (13.3) 16 (17.2)
Gastrointestinal disorders
   Constipation 6 (7.2) 6 (7.2) 7 (7.5)
   Diarrhea 12 (14.5) 13 (15.7) 11 (11.8)
   Gastroesophageal reflux disease 5 (6.0) 7 (8.4) 7 (7.5)
   Inguinal hernia 0 (0.0) 4 (4.8) 5 (5.4)
   Teething 10 (12.0) 9 (10.8) 16 (17.2)
General disorders and administration-site conditions
   Injection site erythema 3 (3.6) 9 (10.8) 8 (8.6)
   Irritability 10 (12.0) 11 (13.3) 11 (11.8)
   Pyrexia 6 (7.2) 8 (9.6) 11 (11.8)
Infections and infestations
   Bronchiolitis 11 (13.3) 7 (8.4) 5 (5.4)
   Bronchitis 12 (14.5) 13 (15.7) 13 (14.0)
   Bronchitis acute 3 (3.6) 7 (8.4) 6 (6.5)
   Gastroenteritis 8 (9.6) 4 (4.8) 5 (5.4)
   Lower respiratory tract infection 7 (8.4) 7 (8.4) 6 (6.5)
   Nasopharyngitis 25 (30.1) 26 (31.3) 23 (24.7)
   Oral candidiasis 2 (2.4) 5 (6.0) 2 (2.2)
   Otitis media acute 2 (2.4) 0 (0.0) 5 (5.4)
   Pharyngitis 7 (8.4) 4 (4.8) 10 (10.8)
   Rhinitis 10 (12.0) 14 (16.9) 8 (8.6)
   Upper respiratory tract infection 17 (20.5) 16 (19.3) 18 (19.4)
Laboratory investigation abnormalities
   Alanine aminotransferase increased 1 (1.2) 1 (1.2) 5 (5.4)
Nervous system disorders
   Hypertonia 5 (6.0) 1 (1.2) 0 (0.0)
Respiratory, thoracic, and mediastinal disorders
   Cough 6 (7.2) 4 (4.8) 5 (5.4)
   Nasal congestion 7 (8.4) 1 (1.2) 3 (3.2)
   Rhinorrhoea 3 (3.6) 5 (6.0) 1 (1.1)
   Wheezing 15 (18.1) 8 (9.6) 10 (10.8)
Skin and subcutaneous disorders
   Dermatitis diaper 5 (6.0) 10 (12.0) 10 (10.8)
   Eczema 1 (1.2) 5 (6.0) 4 (4.3)
   Rash 3 (3.6) 5 (6.0) 4 (4.3)
   Seborrhoeic dermatitis 4 (4.8) 1 (1.2) 5 (5.4)
  1. aMedDRA (version 9.1) system organ classes and preferred terms are shown.