Table 2

Safety issues: AEs and ADRs

Intensive therapy (n = 2,511)Standard therapy (n = 2,518)
Events (n)Patients (n [%])Events (n)Patients (n [%])P value
AEs
 Total7,8321,890 (75.3)8,1891,894 (75.2)0.97
 Serious815535 (21.3)901554 (22.0)0.55
ADRs
 Total368253 (10.1)218168 (6.7)<0.001
 Serious4132 (1.3)2823 (0.9)0.22
Main AEs
 Hepatobiliary disorders
  Total8271 (2.8)5248 (1.9)0.03
  Serious2922 (0.9)1413 (0.5)0.13
 Renal and urinary disorders
  Total200166 (6.6)250215 (8.5)0.01
  Serious2621 (0.8)2828 (1.1)0.39
 Rhabdomyolysis
  Total33 (0.1)44 (0.2)1.00
  Serious11 (0.0)11 (0.0)1.00
 Myopathy
  Total11 (0.0)000.50
  Serious11 (0.0)000.50
 Cancer*
  Total132114 (4.5)107120 (4.2)0.63
  Serious9481 (3.2)9180 (3.2)0.94
  • P values were calculated using the Fisher exact test.

  • *Including neoplasms benign, malignant, and unspecified, including cysts and polyps.