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Table 2 Number of patients (%) with at least one adverse event (AE), by time interval (safety analysis set)

From: Safety and efficacy of long-term esomeprazole 20 mg in Japanese patients with a history of peptic ulcer receiving daily non-steroidal anti-inflammatory drugs

  Esomeprazole 20 mg once daily
0–24 weeks (n=130) 24–52 weeks (n=116) 0–52 weeks (n=130)
Any AEa 105 (80.8) 93 (80.2) 123 (94.6)
  Nasopharyngitis 26 (20.0) 22 (19.0) 38 (29.2)
  Rheumatoid arthritis aggravated 13 (10.0) 4 (3.4) 17 (13.1)
  Upper abdominal pain 8 (6.2) 8 (6.9) 14 (10.8)
  Constipation 7 (5.4) 5 (4.3) 12 (9.2)
  Diarrhoea 6 (4.6) 5 (4.3) 11 (8.5)
  Stomach discomfort 6 (4.6) 4 (3.4) 10 (7.7)
  Osteoarthritis 4 (3.1) 5 (4.3) 9 (6.9)
  Headache 6 (4.6) 2 (1.7) 8 (6.2)
  Nausea 0 8 (6.9) 8 (6.2)
  Anorexia 3 (2.3) 4 (3.4) 7 (5.4)
  Arthralgia 3 (2.3) 4 (3.4) 7 (5.4)
  Contusion 4 (3.1) 4 (3.4) 7 (5.4)
  Hypertension 4 (3.1) 3 (2.6) 7 (5.4)
  Stomatitis 2 (1.5) 5 (4.3) 7 (5.4)
  Vomiting 3 (2.3) 4 (3.4) 7 (5.4)
Severe AEs 2 (1.5) 1 (0.9) 3 (2.3)
Non-fatal serious AEs 13 (10.0) 5 (3.8) 18 (13.8)
AEs leading to treatment discontinuationb 5 (3.8) 1 (0.9) 6 (4.6)
  1. aOnly events reported for >5% of patients are listed. Information on AEs was collected according to standard regulatory requirements, an AE being defined as the development of an undesirable medical condition (or the deterioration of a pre-existing medical condition) following or during exposure to study medication. In this regard, an undesirable medical condition was considered to be symptoms, signs or the abnormal results of any investigation.
  2. bIncluding erosive gastritis (n=2), cerebral infarction (n=1), sore throat (n=1), lung tumour (n=1) and influenza A virus infection (n=1).