Study: NCT01714310

Adverse event: Wish to be dead
Serious: no
Organ System: Psychiatric disorders
Notes: Endorsed on Columbia Suicide Severity Rating Scale
Frequency: 1 affected / 12 at risk

Adverse event: Suicidal ideation without intent
Serious: no
Organ System: Psychiatric disorders
Notes: Endorsed on Columbia Suicide Severity Rating Scale
Frequency: 1 affected / 12 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Clinically significant symptom with post baseline onset based on parent completed Physical Symptoms Checklist.
Frequency: 1 affected / 12 at risk

Adverse event: Feeling drowsy/sleep
Serious: no
Organ System: General disorders
Notes: Clinically significant symptom with post baseline onset based on parent completed Physical Symptoms Checklist.
Frequency: 1 affected / 12 at risk

Adverse event: Nausea/vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Clinically significant symptom with post baseline onset based on parent completed Physical Symptoms Checklist.
Frequency: 1 affected / 12 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Clinically significant symptom with post baseline onset based on parent completed Physical Symptoms Checklist.
Frequency: 2 affected / 12 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: Clinically significant symptom with post baseline onset based on parent completed Physical Symptoms Checklist.
Frequency: 3 affected / 12 at risk

Adverse event: Restless/uncomfortable urge to move
Serious: no
Organ System: General disorders
Notes: Clinically significant symptom with post baseline onset based on parent completed Physical Symptoms Checklist.
Frequency: 1 affected / 12 at risk

Adverse event: Chest pain
Serious: no
Organ System: Cardiac disorders
Notes: Clinically significant symptom with post baseline onset based on parent completed Physical Symptoms Checklist.
Frequency: 1 affected / 12 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Notes: Clinically significant symptom with post baseline onset based on parent completed Physical Symptoms Checklist.
Frequency: 1 affected / 12 at risk

Adverse event: Trouble sleeping
Serious: no
Organ System: Psychiatric disorders
Notes: Clinically significant symptom with post baseline onset based on parent completed Physical Symptoms Checklist.
Frequency: 1 affected / 12 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Notes: Clinically significant symptom with post baseline onset based on parent completed Physical Symptoms Checklist.
Frequency: 1 affected / 12 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: General disorders
Notes: Clinically significant symptom with post baseline onset based on parent completed Physical Symptoms Checklist.
Frequency: 7 affected / 12 at risk

Adverse event: Tic
Serious: no
Organ System: Nervous system disorders
Notes: Clinically significant symptom with post baseline onset based on parent completed Physical Symptoms Checklist.
Frequency: 2 affected / 12 at risk

Adverse event: Euphoric mood
Serious: no
Organ System: Psychiatric disorders
Notes: Clinically significant symptom with post baseline onset based on parent completed Physical Symptoms Checklist.
Frequency: 1 affected / 12 at risk

Adverse event: Talks less with others
Serious: no
Organ System: Psychiatric disorders
Notes: Clinically significant symptom with post baseline onset based on parent completed Physical Symptoms Checklist.
Frequency: 1 affected / 12 at risk

Adverse event: Bites fingernails
Serious: no
Organ System: Nervous system disorders
Notes: Clinically significant symptom with post baseline onset based on parent completed Physical Symptoms Checklist.
Frequency: 3 affected / 12 at risk

Adverse event: Wish to be dead
Serious: no
Organ System: Psychiatric disorders
Notes: Endorsed on Columbia Suicide Severity Rating Scale
Frequency: 2 affected / 14 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Clinically significant symptom with post baseline onset based on parent completed Physical Symptoms Checklist.
Frequency: 1 affected / 14 at risk

Adverse event: Feeling drowsy/sleep
Serious: no
Organ System: General disorders
Notes: Clinically significant symptom with post baseline onset based on parent completed Physical Symptoms Checklist.
Frequency: 1 affected / 14 at risk

Adverse event: Dry mouth
Serious: no
Organ System: General disorders
Notes: Clinically significant symptom with post baseline onset based on parent completed Physical Symptoms Checklist.
Frequency: 3 affected / 14 at risk

Adverse event: Stomach pain/ache
Serious: no
Organ System: Gastrointestinal disorders
Notes: Clinically significant symptom with post baseline onset based on parent completed Physical Symptoms Checklist.
Frequency: 1 affected / 14 at risk

Adverse event: Nausea/vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Clinically significant symptom with post baseline onset based on parent completed Physical Symptoms Checklist.
Frequency: 1 affected / 14 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Clinically significant symptom with post baseline onset based on parent completed Physical Symptoms Checklist.
Frequency: 1 affected / 14 at risk

Adverse event: Restless/uncomfortable urge to move
Serious: no
Organ System: General disorders
Notes: Clinically significant symptom with post baseline onset based on parent completed Physical Symptoms Checklist.
Frequency: 2 affected / 14 at risk

Adverse event: Heart skips beats
Serious: no
Organ System: Cardiac disorders
Notes: Clinically significant symptom with post baseline onset based on parent completed Physical Symptoms Checklist.
Frequency: 2 affected / 14 at risk

Adverse event: Racing heart
Serious: no
Organ System: Cardiac disorders
Notes: Clinically significant symptom with post baseline onset based on parent completed Physical Symptoms Checklist.
Frequency: 2 affected / 14 at risk

Adverse event: Trouble sleeping
Serious: no
Organ System: Psychiatric disorders
Notes: Clinically significant symptom with post baseline onset based on parent completed Physical Symptoms Checklist.
Frequency: 4 affected / 14 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Notes: Clinically significant symptom with post baseline onset based on parent completed Physical Symptoms Checklist.
Frequency: 2 affected / 14 at risk

Adverse event: Nightmare
Serious: no
Organ System: Psychiatric disorders
Notes: Clinically significant symptom with post baseline onset based on parent completed Physical Symptoms Checklist.
Frequency: 2 affected / 14 at risk

Adverse event: Excessive sweating
Serious: no
Organ System: Nervous system disorders
Notes: Clinically significant symptom with post baseline onset based on parent completed Physical Symptoms Checklist.
Frequency: 1 affected / 14 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: General disorders
Notes: Clinically significant symptom with post baseline onset based on parent completed Physical Symptoms Checklist.
Frequency: 6 affected / 14 at risk

Adverse event: Tic
Serious: no
Organ System: Nervous system disorders
Notes: Clinically significant symptom with post baseline onset based on parent completed Physical Symptoms Checklist.
Frequency: 3 affected / 14 at risk

Adverse event: Euphoric mood
Serious: no
Organ System: Psychiatric disorders
Notes: Clinically significant symptom with post baseline onset based on parent completed Physical Symptoms Checklist.
Frequency: 1 affected / 14 at risk

Adverse event: Talks less with others
Serious: no
Organ System: Psychiatric disorders
Notes: Clinically significant symptom with post baseline onset based on parent completed Physical Symptoms Checklist.
Frequency: 2 affected / 14 at risk

Adverse event: Bites fingernails
Serious: no
Organ System: Nervous system disorders
Notes: Clinically significant symptom with post baseline onset based on parent completed Physical Symptoms Checklist.
Frequency: 2 affected / 14 at risk

Adverse event: Prone to crying
Serious: no
Organ System: Psychiatric disorders
Notes: Clinically significant symptom with post baseline onset based on parent completed Physical Symptoms Checklist.
Frequency: 3 affected / 14 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Clinically significant symptom with post baseline onset based on parent completed Physical Symptoms Checklist.
Frequency: 5 affected / 34 at risk

Adverse event: Feeling drowsy/sleep
Serious: no
Organ System: General disorders
Notes: Clinically significant symptom with post baseline onset based on parent completed Physical Symptoms Checklist.
Frequency: 4 affected / 34 at risk

Adverse event: Dry mouth
Serious: no
Organ System: General disorders
Notes: Clinically significant symptom with post baseline onset based on parent completed Physical Symptoms Checklist.
Frequency: 4 affected / 34 at risk

Adverse event: Stomach pain/ache
Serious: no
Organ System: Gastrointestinal disorders
Notes: Clinically significant symptom with post baseline onset based on parent completed Physical Symptoms Checklist.
Frequency: 4 affected / 34 at risk

Adverse event: Nausea/vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Clinically significant symptom with post baseline onset based on parent completed Physical Symptoms Checklist.
Frequency: 2 affected / 34 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Clinically significant symptom with post baseline onset based on parent completed Physical Symptoms Checklist.
Frequency: 3 affected / 34 at risk

Adverse event: Frequent urination
Serious: no
Organ System: Renal and urinary disorders
Notes: Clinically significant symptom with post baseline onset based on parent completed Physical Symptoms Checklist.
Frequency: 1 affected / 34 at risk

Adverse event: Restless/uncomfortable urge to move
Serious: no
Organ System: General disorders
Notes: Clinically significant symptom with post baseline onset based on parent completed Physical Symptoms Checklist.
Frequency: 1 affected / 34 at risk

Adverse event: Racing heart
Serious: no
Organ System: Cardiac disorders
Notes: Clinically significant symptom with post baseline onset based on parent completed Physical Symptoms Checklist.
Frequency: 2 affected / 34 at risk

Adverse event: Chest pain
Serious: no
Organ System: Cardiac disorders
Notes: Clinically significant symptom with post baseline onset based on parent completed Physical Symptoms Checklist.
Frequency: 2 affected / 34 at risk

Adverse event: Trouble sleeping
Serious: no
Organ System: Psychiatric disorders
Notes: Clinically significant symptom with post baseline onset based on parent completed Physical Symptoms Checklist.
Frequency: 9 affected / 34 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Notes: Clinically significant symptom with post baseline onset based on parent completed Physical Symptoms Checklist.
Frequency: 4 affected / 34 at risk

Adverse event: Nightmare
Serious: no
Organ System: Psychiatric disorders
Notes: Clinically significant symptom with post baseline onset based on parent completed Physical Symptoms Checklist.
Frequency: 1 affected / 34 at risk

Adverse event: Excessive sweating
Serious: no
Organ System: Nervous system disorders
Notes: Clinically significant symptom with post baseline onset based on parent completed Physical Symptoms Checklist.
Frequency: 3 affected / 34 at risk

Adverse event: Tremor/shakiness
Serious: no
Organ System: Nervous system disorders
Notes: Clinically significant symptom with post baseline onset based on parent completed Physical Symptoms Checklist.
Frequency: 1 affected / 34 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: General disorders
Notes: Clinically significant symptom with post baseline onset based on parent completed Physical Symptoms Checklist.
Frequency: 21 affected / 34 at risk

Adverse event: Tic
Serious: no
Organ System: Nervous system disorders
Notes: Clinically significant symptom with post baseline onset based on parent completed Physical Symptoms Checklist.
Frequency: 4 affected / 34 at risk

Adverse event: Euphoric mood
Serious: no
Organ System: Psychiatric disorders
Notes: Clinically significant symptom with post baseline onset based on parent completed Physical Symptoms Checklist.
Frequency: 1 affected / 34 at risk

Adverse event: Talks less with others
Serious: no
Organ System: Psychiatric disorders
Notes: Clinically significant symptom with post baseline onset based on parent completed Physical Symptoms Checklist.
Frequency: 1 affected / 34 at risk

Adverse event: Bites fingernails
Serious: no
Organ System: Nervous system disorders
Notes: Clinically significant symptom with post baseline onset based on parent completed Physical Symptoms Checklist.
Frequency: 5 affected / 34 at risk

Adverse event: Prone to crying
Serious: no
Organ System: Psychiatric disorders
Notes: Clinically significant symptom with post baseline onset based on parent completed Physical Symptoms Checklist.
Frequency: 6 affected / 34 at risk