Mixed Motavizumab/Palivizumab (n = 83) | Mixed Palivizumab/Motavizumab (n = 83) | Motavizumab Only (n = 93) | |
---|---|---|---|
Total number of AEs | 405 | 408 | 459 |
Number (%) of subjects reporting ≥1 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) |