TABLE 4.
Adverse reactions occurring in patients >2% (Study 3 and Study 4)
Preferred term (sorted by SOC) | VIMOVO 500 mg/20 mg twice daily (n=246) % | Placebo (n=490) % |
---|---|---|
Gastrointestinal disorders | ||
Dyspepsia | 8 | 12 |
Diarrhea | 6 | 4 |
Abdominal pain upper | 4 | 3 |
Constipation | 4 | 1 |
Nausea | 4 | 4 |
Nervous system disorders | ||
Dizziness | 3 | 2 |
Headache | 3 | 5 |
General disorders and administration site conditions | ||
Peripheral edema | 3 | 1 |
Respiratory, thoracic and mediastinal disorders | ||
Cough | 1 | 3 |
Infections and infestations | ||
Sinusitis | 1 | 2 |