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Table 2 Adverse events in patients with RA (n = 114)

From: Effectiveness of bazedoxifene in preventing glucocorticoid-induced bone loss in rheumatoid arthritis patients

Systemic organ Bazedoxifene group (n = 57) Control group (n = 57)
Adverse events (AE): no. of patients (%) 27 (47.4) 15 (26.3)
 Musculoskeletal 8 (14.0)§ 4 (7.0)§
 Gastrointestinal disorder 8 (14.0) 2 (3.5)§
 Infection* 5 (8.8) 1 (1.8)
 Respiratory 2 (3.5) 4 (7.0)
 Injury 2 (3.5) 3 (5.3)
 Hepatobiliary disorder 3 (5.3) 1 (1.8)
 Skin and subcutaneous tissue disorder 2 (3.5) 2 (3.5)
 General disorder 3 (5.3) 0 (0.0)
 Hot flushing 2 (3.5) 0 (0.0)
 Nervous system disorder 2 (3.5) 0 (0.0)
 Renal and urinary 1 (1.8) 1 (1.8)
 Other 1 (1.8) 3 (5.3)
Total number of AE 46 23
Serious adverse events (SAE): no. of patients (%) 7 (12.3) 10 (17.5)
 Musculoskeletal 3 (5.3) 3 (5.3)
 Infection£ 3 (5.3) 1 (1.8)
 Injury 1 (1.8) 3 (5.3)
 Renal and urinary 0 1 (1.8)
 Eye 0 1 (1.8)
 Malignancy 0 1 (1.8)
Total number of SAE 7 10
  1. *Infection includes one patient with two skin and soft tissues infections, one patient with two reproductive organ infection, one pulmonary, one urinary, and one gum infection in the bazedoxifene group, and one skin and soft tissue infection in the control group
  2. All injuries, except for one skin abrasion in the bazedoxifene group, were fractures, including one rib fracture in the bazedoxifene group, two hips, one spine, and one wrist fracture in the control group
  3. Other includes one psychiatric episode in the bazedoxifene group, one cardiac, one eye disorder, and one malignancy in the control group
  4. £Infections include one pulmonary, one skin and soft tissue, and one urinary infection in the bazedoxifene group, one skin and soft tissue infection in the control group
  5. All injuries were fractures with one rib fracture in the bazedoxifene group, two hip fractures, and one spine fracture in the control group
  6. §One patient with two AEs at different times or sites, One patient with three AS at different times or sites