Study: NCT00632619

Adverse event: threat of self injurious behavior
Serious: yes
Organ System: Psychiatric disorders
Notes: Control who became upset at school when asked to do work and picked up scissors and threatened(but did not attempt) to cut his hand. He was sent for emergency psychiatric assessment. He was discharged home that day at his baseline mental status.
Frequency: 1 affected / 30 at risk

Adverse event: worried/anxious
Serious: no
Organ System: Psychiatric disorders
Notes: measured on the Pittsburgh Side effect rating scale which lists the most common (as well as rare ) adverse events seen with stimulant medications; each is rated on 0-3 with 0-none 3= severe. items rated 2 or more are considered clinically relevant
Frequency: 3 affected / 30 at risk

Adverse event: picking at skin, fingers, nails, lips
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: measured on the Pittsburgh Side effect rating scale which lists the most common (as well as rare ) adverse events seen with stimulant medications; each is rated on 0-3 with 0-none 3= severe. items rated 2 or more are considered clinically relevant
Frequency: 6 affected / 30 at risk

Adverse event: repetitive movements/motor tics
Serious: no
Organ System: Nervous system disorders
Notes: measured on the Pittsburgh Side effect rating scale which lists the most common (as well as rare ) adverse events seen with stimulant medications; each is rated on 0-3 with 0-none 3= severe. items rated 2 or more are considered clinically relevant
Frequency: 1 affected / 30 at risk

Adverse event: dull/tired
Serious: no
Organ System: General disorders
Notes: measured on the Pittsburgh Side effect rating scale which lists the most common (as well as rare ) adverse events seen with stimulant medications; each is rated on 0-3 with 0-none 3= severe. items rated 2 or more are considered clinically relevant
Frequency: 2 affected / 30 at risk

Adverse event: stomachaches
Serious: no
Organ System: Gastrointestinal disorders
Notes: measured on the Pittsburgh Side effect rating scale which lists the most common (as well as rare ) adverse events seen with stimulant medications; each is rated on 0-3 with 0-none 3= severe. items rated 2 or more are considered clinically relevant
Frequency: 1 affected / 30 at risk

Adverse event: crabby or irritable
Serious: no
Organ System: Psychiatric disorders
Notes: measured on the Pittsburgh Side effect rating scale which lists the most common (as well as rare ) adverse events seen with stimulant medications; each is rated on 0-3 with 0-none 3= severe. items rated 2 or more are considered clinically relevant
Frequency: 5 affected / 30 at risk

Adverse event: loss of appetite
Serious: no
Organ System: General disorders
Notes: measured on the Pittsburgh Side effect rating scale which lists the most common (as well as rare ) adverse events seen with stimulant medications; each is rated on 0-3 with 0-none 3= severe. items rated 2 or more are considered clinically relevant
Frequency: 5 affected / 30 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Notes: measured on the Pittsburgh Side effect rating scale which lists the most common (as well as rare ) adverse events seen with stimulant medications; each is rated on 0-3 with 0-none 3= severe. items rated 2 or more are considered clinically relevant
Frequency: 3 affected / 30 at risk

Adverse event: tearful/sad affect
Serious: no
Organ System: Psychiatric disorders
Notes: measured on the Pittsburgh Side effect rating scale which lists the most common (as well as rare ) adverse events seen with stimulant medications; each is rated on 0-3 with 0-none 3= severe. items rated 2 or more are considered clinically relevant.
Frequency: 2 affected / 30 at risk

Adverse event: dull or tired looking
Serious: no
Organ System: Psychiatric disorders
Notes: measured on the Pittsburgh Side effect rating scale which lists the most common (as well as rare ) adverse events seen with stimulant medications; each is rated on 0-3 with 0-none 3= severe. items rated 2 or more are considered clinically relevant
Frequency: 2 affected / 30 at risk

Adverse event: asthma exacerbation
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: subject was admitted to hospital due to worsening of asthma. The child was discharged the next day at baseline health. Therapy treatment had ended 3 weeks prior but participant was on study medication which was deemed unrelated to the event.
Frequency: 1 affected / 35 at risk

Adverse event: appendix removed
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Therapy subject hospitalized for appendicitis. he had appendix removed and discharged home 48hrs later with no sequelae.
Frequency: 1 affected / 35 at risk

Adverse event: aggression towards other
Serious: yes
Organ System: Psychiatric disorders
Notes: Therapy subject with history of aggression who became physically aggressive towards another student and then a teacher. She was hospitalized for 48hrs. No psychotropic medication was started and she was discharged at baseline mental status.
Frequency: 1 affected / 35 at risk

Adverse event: expresssed suicial ideation
Serious: yes
Organ System: Psychiatric disorders
Notes: Therapy subject who expressed suicidal ideation at school but made no attempt. He was hospitalized, diagnosed with pervasive developmental disorder traits \& anxiety disorder. He was started on exclusionary medication so was discontinued from study.
Frequency: 1 affected / 35 at risk

Adverse event: worried/anxious
Serious: no
Organ System: Psychiatric disorders
Notes: measured on the Pittsburgh Side effect rating scale which lists the most common (as well as rare ) adverse events seen with stimulant medications; each is rated on 0-3 with 0-none 3= severe. items rated 2 or more are considered clinically relevant
Frequency: 6 affected / 35 at risk

Adverse event: picking at skin, fingers, nails, lips
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: measured on the Pittsburgh Side effect rating scale which lists the most common (as well as rare ) adverse events seen with stimulant medications; each is rated on 0-3 with 0-none 3= severe. items rated 2 or more are considered clinically relevant
Frequency: 6 affected / 35 at risk

Adverse event: repetitive movements/motor tics
Serious: no
Organ System: Nervous system disorders
Notes: measured on the Pittsburgh Side effect rating scale which lists the most common (as well as rare ) adverse events seen with stimulant medications; each is rated on 0-3 with 0-none 3= severe. items rated 2 or more are considered clinically relevant
Frequency: 3 affected / 35 at risk

Adverse event: dull/tired
Serious: no
Organ System: General disorders
Notes: measured on the Pittsburgh Side effect rating scale which lists the most common (as well as rare ) adverse events seen with stimulant medications; each is rated on 0-3 with 0-none 3= severe. items rated 2 or more are considered clinically relevant
Frequency: 1 affected / 35 at risk

Adverse event: stomachaches
Serious: no
Organ System: Gastrointestinal disorders
Notes: measured on the Pittsburgh Side effect rating scale which lists the most common (as well as rare ) adverse events seen with stimulant medications; each is rated on 0-3 with 0-none 3= severe. items rated 2 or more are considered clinically relevant
Frequency: 2 affected / 35 at risk

Adverse event: crabby or irritable
Serious: no
Organ System: Psychiatric disorders
Notes: measured on the Pittsburgh Side effect rating scale which lists the most common (as well as rare ) adverse events seen with stimulant medications; each is rated on 0-3 with 0-none 3= severe. items rated 2 or more are considered clinically relevant
Frequency: 9 affected / 35 at risk

Adverse event: loss of appetite
Serious: no
Organ System: General disorders
Notes: measured on the Pittsburgh Side effect rating scale which lists the most common (as well as rare ) adverse events seen with stimulant medications; each is rated on 0-3 with 0-none 3= severe. items rated 2 or more are considered clinically relevant
Frequency: 6 affected / 35 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Notes: measured on the Pittsburgh Side effect rating scale which lists the most common (as well as rare ) adverse events seen with stimulant medications; each is rated on 0-3 with 0-none 3= severe. items rated 2 or more are considered clinically relevant
Frequency: 6 affected / 35 at risk

Adverse event: tearful/sad affect
Serious: no
Organ System: Psychiatric disorders
Notes: measured on the Pittsburgh Side effect rating scale which lists the most common (as well as rare ) adverse events seen with stimulant medications; each is rated on 0-3 with 0-none 3= severe. items rated 2 or more are considered clinically relevant.
Frequency: 1 affected / 35 at risk

Adverse event: dull or tired looking
Serious: no
Organ System: Psychiatric disorders
Notes: measured on the Pittsburgh Side effect rating scale which lists the most common (as well as rare ) adverse events seen with stimulant medications; each is rated on 0-3 with 0-none 3= severe. items rated 2 or more are considered clinically relevant
Frequency: 1 affected / 35 at risk