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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.