Study: NCT02039908

Adverse event: Hospitalized
Serious: yes
Organ System: Psychiatric disorders
Notes: Referred by parent for inpatient psychiatric treatment due to comorbid mental health issues.
Frequency: 1 affected / 129 at risk

Adverse event: Appetite Loss
Serious: no
Organ System: Gastrointestinal disorders
Notes: Moderate or Severe Appetite Loss
Frequency: 66 affected / 129 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 52 affected / 129 at risk

Adverse event: Motor Tics
Serious: no
Organ System: General disorders
Notes: Rating of moderate or severe motor tics
Frequency: 17 affected / 129 at risk

Adverse event: Buccal-lingual movements
Serious: no
Organ System: General disorders
Notes: Parent rating of moderate or severe buccal-lingual movements
Frequency: 15 affected / 129 at risk

Adverse event: Picking at skin, nailbiting
Serious: no
Organ System: General disorders
Notes: Parent rating of moderate or severe picking, nail-biting, etc.
Frequency: 37 affected / 129 at risk

Adverse event: Worried/Anxious
Serious: no
Organ System: General disorders
Notes: Parent rating of moderate or severe worry/anxiety
Frequency: 27 affected / 129 at risk

Adverse event: Dull, tired, listless
Serious: no
Organ System: General disorders
Notes: Parent rating of moderate or severe dullness/tiredness/listlessness
Frequency: 27 affected / 129 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Notes: Parent rating of moderate or severe headache
Frequency: 17 affected / 129 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Notes: Parent rating of moderate or severe stomach ache
Frequency: 23 affected / 129 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Notes: Parent rating of moderate or severe irritability
Frequency: 42 affected / 129 at risk

Adverse event: Tearful, depressed
Serious: no
Organ System: General disorders
Notes: Parent rating of moderate or severe tearfulness or sadness
Frequency: 25 affected / 129 at risk

Adverse event: Social avoidant behaviour
Serious: no
Organ System: General disorders
Notes: Parent rating of moderate or severe social withdrawal
Frequency: 13 affected / 129 at risk

Adverse event: Appetite Loss
Serious: no
Organ System: Gastrointestinal disorders
Notes: Moderate or Severe Appetite Loss
Frequency: 72 affected / 138 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 56 affected / 138 at risk

Adverse event: Motor Tics
Serious: no
Organ System: General disorders
Notes: Rating of moderate or severe motor tics
Frequency: 19 affected / 138 at risk

Adverse event: Buccal-lingual movements
Serious: no
Organ System: General disorders
Notes: Parent rating of moderate or severe buccal-lingual movements
Frequency: 17 affected / 138 at risk

Adverse event: Picking at skin, nailbiting
Serious: no
Organ System: General disorders
Notes: Parent rating of moderate or severe picking, nail-biting, etc.
Frequency: 28 affected / 138 at risk

Adverse event: Worried/Anxious
Serious: no
Organ System: General disorders
Notes: Parent rating of moderate or severe worry/anxiety
Frequency: 30 affected / 138 at risk

Adverse event: Dull, tired, listless
Serious: no
Organ System: General disorders
Notes: Parent rating of moderate or severe dullness/tiredness/listlessness
Frequency: 30 affected / 138 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Notes: Parent rating of moderate or severe headache
Frequency: 19 affected / 138 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Notes: Parent rating of moderate or severe stomach ache
Frequency: 24 affected / 138 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Notes: Parent rating of moderate or severe irritability
Frequency: 46 affected / 138 at risk

Adverse event: Tearful, depressed
Serious: no
Organ System: General disorders
Notes: Parent rating of moderate or severe tearfulness or sadness
Frequency: 27 affected / 138 at risk

Adverse event: Social avoidant behaviour
Serious: no
Organ System: General disorders
Notes: Parent rating of moderate or severe social withdrawal
Frequency: 14 affected / 138 at risk

Adverse event: Hospitalized
Serious: yes
Organ System: Psychiatric disorders
Notes: Referred by parent for inpatient psychiatric treatment due to comorbid mental health issues.
Frequency: 1 affected / 121 at risk

Adverse event: Appetite Loss
Serious: no
Organ System: Gastrointestinal disorders
Notes: Moderate or Severe Appetite Loss
Frequency: 46 affected / 121 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 46 affected / 121 at risk

Adverse event: Motor Tics
Serious: no
Organ System: General disorders
Notes: Rating of moderate or severe motor tics
Frequency: 17 affected / 121 at risk

Adverse event: Buccal-lingual movements
Serious: no
Organ System: General disorders
Notes: Parent rating of moderate or severe buccal-lingual movements
Frequency: 10 affected / 121 at risk

Adverse event: Picking at skin, nailbiting
Serious: no
Organ System: General disorders
Notes: Parent rating of moderate or severe picking, nail-biting, etc.
Frequency: 38 affected / 121 at risk

Adverse event: Worried/Anxious
Serious: no
Organ System: General disorders
Notes: Parent rating of moderate or severe worry/anxiety
Frequency: 25 affected / 121 at risk

Adverse event: Dull, tired, listless
Serious: no
Organ System: General disorders
Notes: Parent rating of moderate or severe dullness/tiredness/listlessness
Frequency: 14 affected / 121 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Notes: Parent rating of moderate or severe headache
Frequency: 15 affected / 121 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Notes: Parent rating of moderate or severe stomach ache
Frequency: 21 affected / 121 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Notes: Parent rating of moderate or severe irritability
Frequency: 38 affected / 121 at risk

Adverse event: Tearful, depressed
Serious: no
Organ System: General disorders
Notes: Parent rating of moderate or severe tearfulness or sadness
Frequency: 14 affected / 121 at risk

Adverse event: Social avoidant behaviour
Serious: no
Organ System: General disorders
Notes: Parent rating of moderate or severe social withdrawal
Frequency: 5 affected / 121 at risk

Adverse event: Hospitalized
Serious: yes
Organ System: Psychiatric disorders
Notes: Referred by parent for inpatient psychiatric treatment due to comorbid mental health issues.
Frequency: 1 affected / 124 at risk

Adverse event: Appetite Loss
Serious: no
Organ System: Gastrointestinal disorders
Notes: Moderate or Severe Appetite Loss
Frequency: 51 affected / 124 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 34 affected / 124 at risk

Adverse event: Motor Tics
Serious: no
Organ System: General disorders
Notes: Rating of moderate or severe motor tics
Frequency: 14 affected / 124 at risk

Adverse event: Buccal-lingual movements
Serious: no
Organ System: General disorders
Notes: Parent rating of moderate or severe buccal-lingual movements
Frequency: 16 affected / 124 at risk

Adverse event: Picking at skin, nailbiting
Serious: no
Organ System: General disorders
Notes: Parent rating of moderate or severe picking, nail-biting, etc.
Frequency: 37 affected / 124 at risk

Adverse event: Worried/Anxious
Serious: no
Organ System: General disorders
Notes: Parent rating of moderate or severe worry/anxiety
Frequency: 34 affected / 124 at risk

Adverse event: Dull, tired, listless
Serious: no
Organ System: General disorders
Notes: Parent rating of moderate or severe dullness/tiredness/listlessness
Frequency: 19 affected / 124 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Notes: Parent rating of moderate or severe headache
Frequency: 14 affected / 124 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Notes: Parent rating of moderate or severe stomach ache
Frequency: 17 affected / 124 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Notes: Parent rating of moderate or severe irritability
Frequency: 36 affected / 124 at risk

Adverse event: Tearful, depressed
Serious: no
Organ System: General disorders
Notes: Parent rating of moderate or severe tearfulness or sadness
Frequency: 20 affected / 124 at risk

Adverse event: Social avoidant behaviour
Serious: no
Organ System: General disorders
Notes: Parent rating of moderate or severe social withdrawal
Frequency: 10 affected / 124 at risk