Study: NCT01308749

Adverse event: Croup infectious
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: unanticipated, unrelated
Frequency: 1 affected / 12 at risk

Adverse event: # of participants with any adverse event
Serious: no
Organ System: General disorders
Frequency: 12 affected / 12 at risk

Adverse event: # with moderate adverse event
Serious: no
Organ System: General disorders
Frequency: 5 affected / 12 at risk

Adverse event: # with severe adverse event
Serious: no
Organ System: General disorders
Frequency: 5 affected / 12 at risk

Adverse event: Insomnia
Serious: no
Organ System: Nervous system disorders
Notes: includes initial, midcycle and terminal of any severity
Frequency: 4 affected / 12 at risk

Adverse event: Anger or irritability
Serious: no
Organ System: Psychiatric disorders
Notes: any severity
Frequency: 1 affected / 12 at risk

Adverse event: Negativism
Serious: no
Organ System: Psychiatric disorders
Notes: any severity
Frequency: 2 affected / 12 at risk

Adverse event: mood lability
Serious: no
Organ System: Psychiatric disorders
Notes: any severity
Frequency: 1 affected / 12 at risk

Adverse event: # who withdrew due to AE
Serious: no
Organ System: General disorders
Frequency: 1 affected / 12 at risk

Adverse event: Aggression
Serious: no
Organ System: Psychiatric disorders
Notes: any severity
Frequency: 1 affected / 12 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: any severity
Frequency: 3 affected / 12 at risk

Adverse event: Agitation
Serious: no
Organ System: Nervous system disorders
Notes: anyseverity
Frequency: 2 affected / 12 at risk

Adverse event: # of participants with any adverse event
Serious: no
Organ System: General disorders
Frequency: 10 affected / 13 at risk

Adverse event: # with moderate adverse event
Serious: no
Organ System: General disorders
Frequency: 9 affected / 13 at risk

Adverse event: # with severe adverse event
Serious: no
Organ System: General disorders
Frequency: 2 affected / 13 at risk

Adverse event: Insomnia
Serious: no
Organ System: Nervous system disorders
Notes: includes initial, midcycle and terminal of any severity
Frequency: 5 affected / 13 at risk

Adverse event: Anger or irritability
Serious: no
Organ System: Psychiatric disorders
Notes: any severity
Frequency: 3 affected / 13 at risk

Adverse event: Negativism
Serious: no
Organ System: Psychiatric disorders
Notes: any severity
Frequency: 3 affected / 13 at risk

Adverse event: mood lability
Serious: no
Organ System: Psychiatric disorders
Notes: any severity
Frequency: 1 affected / 13 at risk

Adverse event: Aggression
Serious: no
Organ System: Psychiatric disorders
Notes: any severity
Frequency: 4 affected / 13 at risk

Adverse event: Agitation
Serious: no
Organ System: Nervous system disorders
Notes: anyseverity
Frequency: 2 affected / 13 at risk

Adverse event: # of participants with any adverse event
Serious: no
Organ System: General disorders
Frequency: 7 affected / 11 at risk

Adverse event: # with moderate adverse event
Serious: no
Organ System: General disorders
Frequency: 3 affected / 11 at risk

Adverse event: # with severe adverse event
Serious: no
Organ System: General disorders
Frequency: 1 affected / 11 at risk

Adverse event: Insomnia
Serious: no
Organ System: Nervous system disorders
Notes: includes initial, midcycle and terminal of any severity
Frequency: 1 affected / 11 at risk

Adverse event: Anger or irritability
Serious: no
Organ System: Psychiatric disorders
Notes: any severity
Frequency: 1 affected / 11 at risk

Adverse event: Negativism
Serious: no
Organ System: Psychiatric disorders
Notes: any severity
Frequency: 1 affected / 11 at risk

Adverse event: mood lability
Serious: no
Organ System: Psychiatric disorders
Notes: any severity
Frequency: 1 affected / 11 at risk

Adverse event: Aggression
Serious: no
Organ System: Psychiatric disorders
Notes: any severity
Frequency: 1 affected / 11 at risk

Adverse event: Agitation
Serious: no
Organ System: Nervous system disorders
Notes: anyseverity
Frequency: 1 affected / 11 at risk

Adverse event: # of participants with any adverse event
Serious: no
Organ System: General disorders
Frequency: 12 affected / 13 at risk

Adverse event: # with moderate adverse event
Serious: no
Organ System: General disorders
Frequency: 6 affected / 13 at risk

Adverse event: # with severe adverse event
Serious: no
Organ System: General disorders
Frequency: 1 affected / 13 at risk

Adverse event: Insomnia
Serious: no
Organ System: Nervous system disorders
Notes: includes initial, midcycle and terminal of any severity
Frequency: 2 affected / 13 at risk

Adverse event: Anger or irritability
Serious: no
Organ System: Psychiatric disorders
Notes: any severity
Frequency: 4 affected / 13 at risk

Adverse event: Negativism
Serious: no
Organ System: Psychiatric disorders
Notes: any severity
Frequency: 4 affected / 13 at risk

Adverse event: mood lability
Serious: no
Organ System: Psychiatric disorders
Notes: any severity
Frequency: 3 affected / 13 at risk

Adverse event: # who withdrew due to AE
Serious: no
Organ System: General disorders
Frequency: 1 affected / 13 at risk

Adverse event: Aggression
Serious: no
Organ System: Psychiatric disorders
Notes: any severity
Frequency: 2 affected / 13 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: any severity
Frequency: 1 affected / 13 at risk

Adverse event: Agitation
Serious: no
Organ System: Nervous system disorders
Notes: anyseverity
Frequency: 4 affected / 13 at risk