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Table 3 Adverse events

From: Relieving nasal congestion in children with seasonal and perennial allergic rhinitis: efficacy and safety studies of mometasone furoate nasal spray

 

 Study 1 (SAR)

Study 2 (PAR)

Subjects reporting AE, n (%)

MFNS 100 μg (n=135)

Placebo (n=136)

MFNS 100 μg (n=190)

Placebo (n=191)

AEs reported by ≥5% of patients

Any, 91 (67)

Any, 93 (67)

Any, 108 (57)

Any, 110 (58)

Fever, 9 (7)

Fever, 11 (8)

Coughing, 27 (14)

Coughing, 33 (17)

Headache, 30 (22)

Headache, 26 (19)

Headache, 24 (13)

Headache, 25 (13)

Vomiting, 7 (5)

Asthma, 12 (9)

Fever, 16 (8)

Fever, 15 (8)

Asthma, 8 (6)

Coughing, 11 (8)

Pharyngitis, 14 (7)

Pharyngitis, 14 (7)

Coughing, 7 (5)

Epistaxis, 10 (7)

Epistaxis, 12 (6)

Epistaxis, 17 (9)

Epistaxis, 12 (9)

Pharyngitis, 15 (11)

 

Viral infection, 14 (7)

Pharyngitis, 9 (7)

Sneezing, 7 (5)

  

Treatment-related AEs, n (%)

Any, 27 (20)

Any, 31 (23)

Any, 28 (15)

Any, 31 (16)

Chest pain, 1 (1)

Edema, 1 (1)

Erythema, 1 (1)

Fatigue, 1 (1)

Fatigue, 1 (1)

Headache, 8 (6)

Fever, 1 (1)

Fever, 2 (1)

Headache, 4 (3)

Nausea, 1 (1)

Headache, 6 (3)

Headache, 5 (3)

Diarrhea, 1 (1)

Insomnia, 1 (1)

Malaise, 1 (1)

Crying, abnormal, 1 (1)

Dyspepsia, 1 (1)

Somnolence, 1 (1)

Dyspepsia, 1 (1)

Dizziness, 1 (1)

Nausea, 1 (1)

Coughing, 1 (1)

Nausea, 1 (1)

Hypokinesia, 1 (1)

Vomiting, 1 (1)

Epistaxis, 9 (7)

Vomiting, 2 (1)

Diarrhea, 1 (1)

Asthma aggravated, 2

Nasal burning, 2 (1)

Earache, 1 (1)

Dyspepsia, 2 (1)

(1)

Pharyngitis, 3 (2)

Leukorrhea, 1 (1)

Nausea, 1 (1)

Bronchitis, 1 (1)

Rhinitis, 2 (1)

Otitis media, 1 (1)

Vomiting, 1 (1)

Coughing, 2 (1)

Sneezing, 6 (4)

Coughing, 3 (2)

Appetite increased, 1 (1)

Dyspnea, 1 (1)

Upper respiratory tract infection, 1 (1)

Epistaxis, 7 (4)

Infection bacterial, 1 (1)

Epistaxis, 8 (6)

 

Nasal burning, 1 (1)

Coughing, 5 (3)

Nasal irritation, 3 (2)

 

Nasal irritation, 1 (1)

Epistaxis, 9 (5)

Pharyngitis, 1 (1)

 

Pharyngitis, 2 (1)

Nasal congestion, 1 (1)

Rhinitis, 1 (1)

 

Rhinorrhea, 1 (1)

Nasal irritation, 1 (1)

Sneezing, 4 (3)

 

Sneezing, 5 (3)

Pharyngitis, 1 (1)

  

Eczema, 1 (1)

Rhinitis, 1 (1)

  

Rash, 2 (1)

Rhinorrhea, 1 (1)

  

Urticaria, 1 (1)

Sneezing, 7 (4)

   

Dermatitis, 1 (1)

   

Rash, 1 (1)

   

Urticaria, 1 (1)

   

Conjunctivitis, 1 (1)

Severe treatment-related AEs, n (%)

1 (1) (headache)

4 (3) (epistaxis, rhinitis, sneezing, conjunctivitis)

1 (1) (dyspepsia)

1 (1) (nasal congestion)

  1. AEs, adverse events; MFNS, mometasone furoate nasal spray; PAR, perennial allergic rhinitis; SAR, seasonal allergic rhinitis.