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) |