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Table 4 Incidence of adverse events

From: Effects of testosterone treatment on body fat and lean mass in obese men on a hypocaloric diet: a randomised controlled trial

  Testosterone group
n = 49
Placebo group
n = 51
Overall
 Any adverse event 10 8
 Withdrawal due to serious adverse eventa 2 1
Prostate
 Rise in prostate-specific antigen by > 1.0 μg/L 5* 0
 Prostatitis 1 0
 Rise in haemoglobin to > 180 g/Lb 1 0
 Cardiovascular 1 1
 Gastrointestinal 0 2
 Dermatological 2 4
 Neurological 0 1
  1. *P = 0.02
  2. aA total of three men were withdrawn from the study: one man receiving testosterone experienced angina requiring coronary artery stent insertion, one man receiving testosterone had a rise in prostate-specific antigen above the pre-determined safety level (>5.5 μg/L) at week 26, one man receiving placebo experienced ventricular fibrillation and was resuscitated
  3. bThe rise in haemoglobin above the pre-determined safety level (>180 g/L) occurred at study end