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. 2015 Sep 17;3(4):269–279. doi: 10.1002/sm2.80

Table 4.

Drug‐related treatment‐emergent adverse events*

System organ class (preferred term) 50 mg SC TE (n = 14) 100 mg SC TE (n = 15) 200 mg IM TE (n = 10)
n (%) n (%) n (%)
Patients with any drug‐related TEAE 2 (14.3) 2 (13.3) 0 (0.0)
General disorders and administration site conditions 1 (7.1) 0 (0.0) 0 (0.0)
Injection site hemorrhage 1 (7.1) 0 (0.0) 0 (0.0)
Psychiatric disorders 1 (7.1) 1 (6.7) 0 (0.0)
Insomnia 1 (7.1) 1 (6.7) 0 (0.0)
Skin and subcutaneous tissue disorders 0 (0.0) 1 (6.7) 0 (0.0)
Acne 0 (0.0) 1 (6.7) 0 (0.0)

*An AE was considered to be a TEAE if the AE started on or after the first dosing of study medication. Percentage was calculated using the number of patients in the column heading as the denominator. Although a patient may have had two or more TEAEs, the patient was counted only once within a system organ class category. The same patient may have contributed to two or more preferred term categories. Injection site ecchymosis (reported term of “left abdominal injection site ecchymosis”, and coded as “injection site ecchymosis” as lower level term and “hemorrhage” as the preferred term because of MedDRA coding specifications). AE = adverse event; IM = intramuscular; SC = subcutaneous; TE = testosterone enanthate; TEAE = treatment‐emergent adverse event