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Table 3 Number of patients (%) with at least one possibly treatment-related adverse event (AE) (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 (n=130)

Possibly treatment-related AEsa

22 (16.9)

  Abnormal hepatic function

2 (1.5)

  Headache

2 (1.5)

  Increased GGT levels

2 (1.5)

  Muscle spasms

2 (1.5)

  Anorexia

1 (0.8)

  Asthma

1 (0.8)

  Benign skin neoplasm

1 (0.8)

  Constipation

1 (0.8)

  Decreased neutrophil count

1 (0.8)

  Decreased platelet count

1 (0.8)

  Dysgeusia

1 (0.8)

  Dysphagia

1 (0.8)

  Erosive gastritis

1 (0.8)

  Erysipelas

1 (0.8)

  Esophageal candidiasis

1 (0.8)

  Gastric polyps (fundic gland polyp)

1 (0.8)

  Hypertension

1 (0.8)

  Increased ALT levels

1 (0.8)

  Increased blood CPK levels

1 (0.8)

  Increased blood urea

1 (0.8)

  Nummular eczema

1 (0.8)

  Pneumonia

1 (0.8)

  Pruritus

1 (0.8)

  Stomach discomfort

1 (0.8)

  Stomatitis

1 (0.8)

  Upper abdominal pain

1 (0.8)

  1. aInformation 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. Abbreviations: ALT, alanine aminotransferase; CPK, creatine phosphokinase; GGT, γ-glutamyltransferase.