Study: NCT00918567

Adverse event: Trouble Sleeping
Serious: no
Organ System: Psychiatric disorders
Notes: computed from combined PSESR ratings from parents and teachers at weeks 1, 3 and 8
Frequency: 4 affected / 29 at risk

Adverse event: stomachaches
Serious: no
Organ System: Gastrointestinal disorders
Notes: computed from combined PSESR ratings from parents and teachers at weeks 1, 3 and 8
Frequency: 8 affected / 29 at risk

Adverse event: appetite loss
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: computed from combined PSESR ratings from parents and teachers at weeks 1, 3 and 8
Frequency: 7 affected / 29 at risk

Adverse event: headaches
Serious: no
Organ System: Nervous system disorders
Notes: computed from combined PSESR ratings from parents and teachers at weeks 1, 3 and 8
Frequency: 5 affected / 29 at risk

Adverse event: motor tics
Serious: no
Organ System: Nervous system disorders
Notes: computed from combined PSESR ratings from parents and teachers at weeks 1, 3 and 8
Frequency: 4 affected / 29 at risk

Adverse event: picking at skin
Serious: no
Organ System: Psychiatric disorders
Notes: computed from combined PSESR ratings from parents and teachers at weeks 1, 3 and 8
Frequency: 9 affected / 29 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Notes: computed from combined PSESR ratings from parents and teachers at weeks 1, 3 and 8
Frequency: 10 affected / 29 at risk

Adverse event: dulled/tired looking
Serious: no
Organ System: Psychiatric disorders
Notes: computed from combined PSESR ratings from parents and teachers at weeks 1, 3 and 8
Frequency: 13 affected / 29 at risk

Adverse event: crabby/irritable
Serious: no
Organ System: Psychiatric disorders
Notes: computed from combined PSESR ratings from parents and teachers at weeks 1, 3 and 8
Frequency: 14 affected / 29 at risk

Adverse event: depressed mood/crying episodes
Serious: no
Organ System: Psychiatric disorders
Notes: computed from PSERS ratings from parents \& teachers at weeks 1,3+8; there were 2 cases (1 per group)of expressed suicidal ideation; these 2 subjects were assessed by study doctors; neither were found to have a genuine desire to commit suicide.
Frequency: 8 affected / 29 at risk

Adverse event: withdrawn from others
Serious: no
Organ System: Psychiatric disorders
Notes: computed from combined PSESR ratings from parents and teachers at weeks 1, 3 and 8
Frequency: 5 affected / 29 at risk

Adverse event: Trouble Sleeping
Serious: no
Organ System: Psychiatric disorders
Notes: computed from combined PSESR ratings from parents and teachers at weeks 1, 3 and 8
Frequency: 3 affected / 27 at risk

Adverse event: stomachaches
Serious: no
Organ System: Gastrointestinal disorders
Notes: computed from combined PSESR ratings from parents and teachers at weeks 1, 3 and 8
Frequency: 4 affected / 27 at risk

Adverse event: appetite loss
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: computed from combined PSESR ratings from parents and teachers at weeks 1, 3 and 8
Frequency: 2 affected / 27 at risk

Adverse event: headaches
Serious: no
Organ System: Nervous system disorders
Notes: computed from combined PSESR ratings from parents and teachers at weeks 1, 3 and 8
Frequency: 3 affected / 27 at risk

Adverse event: motor tics
Serious: no
Organ System: Nervous system disorders
Notes: computed from combined PSESR ratings from parents and teachers at weeks 1, 3 and 8
Frequency: 4 affected / 7 at risk

Adverse event: picking at skin
Serious: no
Organ System: Psychiatric disorders
Notes: computed from combined PSESR ratings from parents and teachers at weeks 1, 3 and 8
Frequency: 10 affected / 27 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Notes: computed from combined PSESR ratings from parents and teachers at weeks 1, 3 and 8
Frequency: 12 affected / 27 at risk

Adverse event: dulled/tired looking
Serious: no
Organ System: Psychiatric disorders
Notes: computed from combined PSESR ratings from parents and teachers at weeks 1, 3 and 8
Frequency: 10 affected / 27 at risk

Adverse event: crabby/irritable
Serious: no
Organ System: Psychiatric disorders
Notes: computed from combined PSESR ratings from parents and teachers at weeks 1, 3 and 8
Frequency: 11 affected / 27 at risk

Adverse event: depressed mood/crying episodes
Serious: no
Organ System: Psychiatric disorders
Notes: computed from PSERS ratings from parents \& teachers at weeks 1,3+8; there were 2 cases (1 per group)of expressed suicidal ideation; these 2 subjects were assessed by study doctors; neither were found to have a genuine desire to commit suicide.
Frequency: 5 affected / 27 at risk

Adverse event: withdrawn from others
Serious: no
Organ System: Psychiatric disorders
Notes: computed from combined PSESR ratings from parents and teachers at weeks 1, 3 and 8
Frequency: 3 affected / 27 at risk