Study: NCT02255565

Adverse event: Difficulty Falling Asleep
Serious: no
Organ System: General disorders
Frequency: 5 affected / 9 at risk

Adverse event: Waking at Night
Serious: no
Organ System: General disorders
Notes: Difficulty remaining asleep throughout the night
Frequency: 2 affected / 9 at risk

Adverse event: Waking up Early
Serious: no
Organ System: General disorders
Notes: Premature awakening in the morning, is too alert to resume sleeping after waking
Frequency: 3 affected / 9 at risk

Adverse event: Nightmare
Serious: no
Organ System: General disorders
Notes: Distressing dreams
Frequency: 1 affected / 9 at risk

Adverse event: Flat Affect / No Emotion
Serious: no
Organ System: Psychiatric disorders
Notes: Complete (or nearly complete) absence of emotional expression.
Frequency: 2 affected / 9 at risk

Adverse event: Rebound at end of day
Serious: no
Organ System: Psychiatric disorders
Notes: An intensification of ADHD symptoms at the end of the day
Frequency: 4 affected / 9 at risk

Adverse event: Aggression
Serious: no
Organ System: Psychiatric disorders
Notes: Behaving in an actively hostile manner
Frequency: 6 affected / 9 at risk

Adverse event: Talks less
Serious: no
Organ System: General disorders
Notes: Child talks less than is normal for him/her.
Frequency: 2 affected / 9 at risk

Adverse event: Uninterested
Serious: no
Organ System: General disorders
Notes: Child appears not to be interested in things or people around him/her
Frequency: 2 affected / 9 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: General disorders
Notes: Reduction in the intensity or frequency of hunger; a reduced desire to eat
Frequency: 3 affected / 9 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Notes: Easily irritated or annoyed
Frequency: 7 affected / 9 at risk

Adverse event: Hostility
Serious: no
Organ System: General disorders
Notes: Showing antagonism and opposition towards people and/or circumstances
Frequency: 6 affected / 9 at risk

Adverse event: Stomachaches
Serious: no
Organ System: General disorders
Notes: Persistent pain localized in the stomach area
Frequency: 2 affected / 9 at risk

Adverse event: Headaches
Serious: no
Organ System: General disorders
Notes: Persistent physical pain in the child's head
Frequency: 2 affected / 9 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Notes: An irresistible urge to fall asleep at inappropriate times
Frequency: 1 affected / 9 at risk

Adverse event: Sad/Unhappy
Serious: no
Organ System: General disorders
Notes: Child appears inappropriately sad (moods is not congruent with setting or circumstance)
Frequency: 1 affected / 9 at risk

Adverse event: Prone to Crying
Serious: no
Organ System: General disorders
Notes: Cries easily or often
Frequency: 4 affected / 9 at risk

Adverse event: Anxious/worries
Serious: no
Organ System: General disorders
Notes: Apprehension, fear, concern, or dread
Frequency: 3 affected / 9 at risk

Adverse event: Bites Fingernails
Serious: no
Organ System: General disorders
Notes: Child bites fingernails or cuticles
Frequency: 2 affected / 9 at risk

Adverse event: Picking
Serious: no
Organ System: General disorders
Notes: Child picks at skin, cuticles, fingernails, etc.
Frequency: 1 affected / 9 at risk

Adverse event: Euphoric/Happy
Serious: no
Organ System: General disorders
Notes: Child appears inappropriately happy (mood is not congruent with setting or circumstance)
Frequency: 3 affected / 9 at risk

Adverse event: Nausea
Serious: no
Organ System: General disorders
Notes: The urge to vomit; child feels like he/she might vomit
Frequency: 1 affected / 9 at risk

Adverse event: Tic
Serious: no
Organ System: Psychiatric disorders
Notes: Child makes repetitive, uncontrollable movements or sounds
Frequency: 2 affected / 9 at risk

Adverse event: Jittery or nervous
Serious: no
Organ System: General disorders
Notes: An edgy, tense state; is easily agitated or anxious
Frequency: 2 affected / 9 at risk

Adverse event: Mood Swings/Lability
Serious: no
Organ System: General disorders
Notes: Unpredictable or easily changeable moods; unstable moods or emotions
Frequency: 5 affected / 9 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: A reduction of strength or energy
Frequency: 1 affected / 9 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: Infrequent bowel movements
Frequency: 2 affected / 9 at risk

Adverse event: Difficulty Falling Asleep
Serious: no
Organ System: General disorders
Frequency: 6 affected / 9 at risk

Adverse event: Waking at Night
Serious: no
Organ System: General disorders
Notes: Difficulty remaining asleep throughout the night
Frequency: 2 affected / 9 at risk

Adverse event: Waking up Early
Serious: no
Organ System: General disorders
Notes: Premature awakening in the morning, is too alert to resume sleeping after waking
Frequency: 5 affected / 9 at risk

Adverse event: Rebound at end of day
Serious: no
Organ System: Psychiatric disorders
Notes: An intensification of ADHD symptoms at the end of the day
Frequency: 4 affected / 9 at risk

Adverse event: Aggression
Serious: no
Organ System: Psychiatric disorders
Notes: Behaving in an actively hostile manner
Frequency: 2 affected / 9 at risk

Adverse event: Talks less
Serious: no
Organ System: General disorders
Notes: Child talks less than is normal for him/her.
Frequency: 1 affected / 9 at risk

Adverse event: Uninterested
Serious: no
Organ System: General disorders
Notes: Child appears not to be interested in things or people around him/her
Frequency: 1 affected / 9 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: General disorders
Notes: Reduction in the intensity or frequency of hunger; a reduced desire to eat
Frequency: 6 affected / 9 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Notes: Easily irritated or annoyed
Frequency: 4 affected / 9 at risk

Adverse event: Hostility
Serious: no
Organ System: General disorders
Notes: Showing antagonism and opposition towards people and/or circumstances
Frequency: 3 affected / 9 at risk

Adverse event: Stomachaches
Serious: no
Organ System: General disorders
Notes: Persistent pain localized in the stomach area
Frequency: 2 affected / 9 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Notes: An irresistible urge to fall asleep at inappropriate times
Frequency: 2 affected / 9 at risk

Adverse event: Sad/Unhappy
Serious: no
Organ System: General disorders
Notes: Child appears inappropriately sad (moods is not congruent with setting or circumstance)
Frequency: 1 affected / 9 at risk

Adverse event: Prone to Crying
Serious: no
Organ System: General disorders
Notes: Cries easily or often
Frequency: 3 affected / 9 at risk

Adverse event: Anxious/worries
Serious: no
Organ System: General disorders
Notes: Apprehension, fear, concern, or dread
Frequency: 3 affected / 9 at risk

Adverse event: Bites Fingernails
Serious: no
Organ System: General disorders
Notes: Child bites fingernails or cuticles
Frequency: 1 affected / 9 at risk

Adverse event: Picking
Serious: no
Organ System: General disorders
Notes: Child picks at skin, cuticles, fingernails, etc.
Frequency: 1 affected / 9 at risk

Adverse event: Euphoric/Happy
Serious: no
Organ System: General disorders
Notes: Child appears inappropriately happy (mood is not congruent with setting or circumstance)
Frequency: 3 affected / 9 at risk

Adverse event: Nausea
Serious: no
Organ System: General disorders
Notes: The urge to vomit; child feels like he/she might vomit
Frequency: 2 affected / 9 at risk

Adverse event: Tic
Serious: no
Organ System: Psychiatric disorders
Notes: Child makes repetitive, uncontrollable movements or sounds
Frequency: 2 affected / 9 at risk

Adverse event: Jittery or nervous
Serious: no
Organ System: General disorders
Notes: An edgy, tense state; is easily agitated or anxious
Frequency: 2 affected / 9 at risk

Adverse event: Mood Swings/Lability
Serious: no
Organ System: General disorders
Notes: Unpredictable or easily changeable moods; unstable moods or emotions
Frequency: 3 affected / 9 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: A reduction of strength or energy
Frequency: 2 affected / 9 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: Infrequent bowel movements
Frequency: 3 affected / 9 at risk

Adverse event: Stares A Lot
Serious: no
Organ System: General disorders
Notes: Child frequently has a fixed look with his/her wide open, looks into space
Frequency: 2 affected / 9 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: General disorders
Notes: Persistent pain localized in the abdomen
Frequency: 1 affected / 9 at risk

Adverse event: Rash
Serious: no
Organ System: General disorders
Notes: Skin becomes reddened, itchy, and/or raised (not due to an insect bite)
Frequency: 1 affected / 9 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Throwing up
Frequency: 1 affected / 9 at risk

Adverse event: Difficulty Falling Asleep
Serious: no
Organ System: General disorders
Frequency: 6 affected / 9 at risk

Adverse event: Waking at Night
Serious: no
Organ System: General disorders
Notes: Difficulty remaining asleep throughout the night
Frequency: 1 affected / 9 at risk

Adverse event: Waking up Early
Serious: no
Organ System: General disorders
Notes: Premature awakening in the morning, is too alert to resume sleeping after waking
Frequency: 2 affected / 9 at risk

Adverse event: Nightmare
Serious: no
Organ System: General disorders
Notes: Distressing dreams
Frequency: 1 affected / 9 at risk

Adverse event: Flat Affect / No Emotion
Serious: no
Organ System: Psychiatric disorders
Notes: Complete (or nearly complete) absence of emotional expression.
Frequency: 2 affected / 9 at risk

Adverse event: Rebound at end of day
Serious: no
Organ System: Psychiatric disorders
Notes: An intensification of ADHD symptoms at the end of the day
Frequency: 5 affected / 9 at risk

Adverse event: Aggression
Serious: no
Organ System: Psychiatric disorders
Notes: Behaving in an actively hostile manner
Frequency: 4 affected / 9 at risk

Adverse event: Talks less
Serious: no
Organ System: General disorders
Notes: Child talks less than is normal for him/her.
Frequency: 2 affected / 9 at risk

Adverse event: Uninterested
Serious: no
Organ System: General disorders
Notes: Child appears not to be interested in things or people around him/her
Frequency: 4 affected / 9 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: General disorders
Notes: Reduction in the intensity or frequency of hunger; a reduced desire to eat
Frequency: 4 affected / 9 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Notes: Easily irritated or annoyed
Frequency: 4 affected / 9 at risk

Adverse event: Hostility
Serious: no
Organ System: General disorders
Notes: Showing antagonism and opposition towards people and/or circumstances
Frequency: 5 affected / 9 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Notes: An irresistible urge to fall asleep at inappropriate times
Frequency: 3 affected / 9 at risk

Adverse event: Prone to Crying
Serious: no
Organ System: General disorders
Notes: Cries easily or often
Frequency: 1 affected / 9 at risk

Adverse event: Anxious/worries
Serious: no
Organ System: General disorders
Notes: Apprehension, fear, concern, or dread
Frequency: 2 affected / 9 at risk

Adverse event: Bites Fingernails
Serious: no
Organ System: General disorders
Notes: Child bites fingernails or cuticles
Frequency: 1 affected / 9 at risk

Adverse event: Picking
Serious: no
Organ System: General disorders
Notes: Child picks at skin, cuticles, fingernails, etc.
Frequency: 3 affected / 9 at risk

Adverse event: Euphoric/Happy
Serious: no
Organ System: General disorders
Notes: Child appears inappropriately happy (mood is not congruent with setting or circumstance)
Frequency: 5 affected / 9 at risk

Adverse event: Tic
Serious: no
Organ System: Psychiatric disorders
Notes: Child makes repetitive, uncontrollable movements or sounds
Frequency: 3 affected / 9 at risk

Adverse event: Jittery or nervous
Serious: no
Organ System: General disorders
Notes: An edgy, tense state; is easily agitated or anxious
Frequency: 1 affected / 9 at risk

Adverse event: Mood Swings/Lability
Serious: no
Organ System: General disorders
Notes: Unpredictable or easily changeable moods; unstable moods or emotions
Frequency: 3 affected / 9 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: A reduction of strength or energy
Frequency: 1 affected / 9 at risk

Adverse event: Stares A Lot
Serious: no
Organ System: General disorders
Notes: Child frequently has a fixed look with his/her wide open, looks into space
Frequency: 3 affected / 9 at risk

Adverse event: Rash
Serious: no
Organ System: General disorders
Notes: Skin becomes reddened, itchy, and/or raised (not due to an insect bite)
Frequency: 3 affected / 9 at risk

Adverse event: Cold Hands and Feet
Serious: no
Organ System: General disorders
Notes: Hands and feet are cold to the touch
Frequency: 1 affected / 9 at risk