Table 4.

Adverse Events during the First Year (Treatment Period) of the Testosterone Trials.^*

Event	Placebo (N = 394)	Testosterone (N = 394)
	no. of participants
Prostate-related event
Increase in PSA level by ≥1.0 ng/ml	8	23
Prostate cancer	0	1
IPSS >19†	26	27
Hemoglobin ≥17.5 g/dl	0	7
Cardiovascular event‡
Myocardial infarction (definite or probable)	1	2
Stroke (definite or probable)	5	5
Death from cardiovascular causes	1	0
Myocardial infarction, stroke, or death from cardiovascular causes	7	7
Serious adverse events
Death	7	3
Hospitalization	78	68
Other§	6	7

^*PSA denotes prostate-specific antigen.

^†The International Prostate Symptom Score (IPSS) questionnaire is used to identify symptoms of benign prostatic hyperplasia. Scores range from 0 to 35, with higher scores indicating more severe symptoms. A score of more than 19 indicates moderately severe lower urinary tract symptoms.

^‡Data on cardiovascular adverse events were collected with the use of a specific questionnaire administered at each visit and also identified from the adverse-event log and the form for reporting serious adverse events (see the protocol). Myocardial infarction, stroke, and death from cardiovascular causes were assessed by two adjudicators.

^§Other serious adverse events were defined as congenital anomaly, disability, a life-threatening event, or an event that may not be immediately life-threatening but is clearly of major clinical significance.