Study: NCT01585831

Adverse event: Acne
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 28 at risk

Adverse event: Increased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 28 at risk

Adverse event: Behavioral agitation
Serious: no
Organ System: Psychiatric disorders
Frequency: 10 affected / 28 at risk

Adverse event: Skin reaction at application site
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 28 at risk

Adverse event: Gynecomstia
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 28 at risk

Adverse event: Pruritus genital
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 28 at risk

Adverse event: Low White Blood Cell count
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 8 affected / 28 at risk

Adverse event: Advance bone age >1 year
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 13 affected / 28 at risk

Adverse event: Transaminase elevation >ULN
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 25 affected / 28 at risk

Adverse event: Testosterone effects in female caregiver
Serious: no
Organ System: Endocrine disorders
Frequency: 2 affected / 28 at risk

Adverse event: Elevated Triglycerides >250mg/dL
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 28 at risk

Adverse event: BASC-2 Critical Item change
Serious: no
Organ System: Psychiatric disorders
Notes: BASC-2 Critical items related to psychiatric symptoms (depression, self-esteem) newly endorsed or increased from baseline
Frequency: 13 affected / 28 at risk

Adverse event: Acne
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 20 at risk

Adverse event: Behavioral agitation
Serious: no
Organ System: Psychiatric disorders
Frequency: 5 affected / 20 at risk

Adverse event: Skin reaction at application site
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 20 at risk

Adverse event: Gynecomstia
Serious: no
Organ System: Endocrine disorders
Frequency: 2 affected / 20 at risk

Adverse event: Pruritus genital
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 20 at risk

Adverse event: Low White Blood Cell count
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 20 at risk

Adverse event: Advance bone age >1 year
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 20 at risk

Adverse event: Transaminase elevation >ULN
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 15 affected / 20 at risk

Adverse event: Testosterone effects in female caregiver
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 20 at risk

Adverse event: Elevated Triglycerides >250mg/dL
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 20 at risk

Adverse event: BASC-2 Critical Item change
Serious: no
Organ System: Psychiatric disorders
Notes: BASC-2 Critical items related to psychiatric symptoms (depression, self-esteem) newly endorsed or increased from baseline
Frequency: 9 affected / 20 at risk