Study: NCT02537678

Adverse event: Child abuse report (children)
Serious: yes
Organ System: Social circumstances
Notes: A child abuse report was made to authorities if there was reasonable cause to suspect child abuse, and it had not already been reported. Query was made to assess if abuse was reported.
Frequency: 12 affected / 182 at risk

Adverse event: Hospitalized due to psychiatric crisis and for evaluation (children)
Serious: yes
Organ System: Psychiatric disorders
Notes: For children: Hospitalized for mental health. All child hospitalizations occured after treatment and before the last 12 month assessment. Interview was used to asses for hospitalizations.
Frequency: 2 affected / 182 at risk

Adverse event: Hospitalized due to gastrointestinal issues (children)
Serious: yes
Organ System: Gastrointestinal disorders
Notes: For children: Hospitalized due to gastrointestinal issues. Child had pending diagnosis of Crohn's disease. Occured between post-treatment and 12 month follow-up assessment.
Frequency: 1 affected / 182 at risk

Adverse event: Hospitalized due to virus (children)
Serious: yes
Organ System: Infections and infestations
Notes: For children: Admitted to the emergency room due to a virus
Frequency: 1 affected / 182 at risk

Adverse event: Suicidal ideation (children)
Serious: yes
Organ System: Psychiatric disorders
Notes: For children: Suicidal ideation. A structured assessment was used to assess for suicidal ideation.
Frequency: 3 affected / 182 at risk

Adverse event: Worsening of posttraumatic stress symptoms (children)
Serious: no
Organ System: Psychiatric disorders
Notes: For Children: Parents, children ages 7-12, therapists, evaluators rated change in child's posttraumatic stress symptoms since the first assessment. Three minimally worse ratings, or much worse, or very much worse were considered as worsening.
Frequency: 9 affected / 182 at risk

Adverse event: Child abuse report (children)
Serious: yes
Organ System: Social circumstances
Notes: A child abuse report was made to authorities if there was reasonable cause to suspect child abuse, and it had not already been reported. Query was made to assess if abuse was reported.
Frequency: 15 affected / 184 at risk

Adverse event: Hospitalized due to psychiatric crisis and for evaluation (children)
Serious: yes
Organ System: Psychiatric disorders
Notes: For children: Hospitalized for mental health. All child hospitalizations occured after treatment and before the last 12 month assessment. Interview was used to asses for hospitalizations.
Frequency: 2 affected / 184 at risk

Adverse event: Heart surgery due to chronic condition (children)
Serious: yes
Organ System: Cardiac disorders
Notes: For children: Heart surgery. Surgery was planned and child was able to complete study treatment.
Frequency: 1 affected / 184 at risk

Adverse event: Suicidal ideation (children)
Serious: yes
Organ System: Psychiatric disorders
Notes: For children: Suicidal ideation. A structured assessment was used to assess for suicidal ideation.
Frequency: 6 affected / 184 at risk

Adverse event: Hospitalized due to prior condition (parents/guardians)
Serious: yes
Organ System: General disorders
Notes: For parents/guardians: Hospitalized for prior condition.
Frequency: 4 affected / 184 at risk

Adverse event: Hospitalized due to meningitis (parents/guardians)
Serious: yes
Organ System: Infections and infestations
Notes: For parents/guardians: Hospitalized due to meningitis
Frequency: 1 affected / 184 at risk

Adverse event: Worsening of posttraumatic stress symptoms (children)
Serious: no
Organ System: Psychiatric disorders
Notes: For Children: Parents, children ages 7-12, therapists, evaluators rated change in child's posttraumatic stress symptoms since the first assessment. Three minimally worse ratings, or much worse, or very much worse were considered as worsening.
Frequency: 16 affected / 184 at risk