Study: NCT03550209

Adverse event: Ear
Serious: no
Organ System: Ear and labyrinth disorders
Notes: Includes ear infection, poor hearing, and fluid in ears.
Frequency: 2 affected / 12 at risk

Adverse event: Eye
Serious: no
Organ System: Eye disorders
Notes: Includes eye irritation and conjunctivitis.
Frequency: 1 affected / 12 at risk

Adverse event: Gastrointestinal
Serious: no
Organ System: Gastrointestinal disorders
Notes: Includes changes in appetite, constipation, diarrhea, stomach pain/discomfort, changes in frequency of bowel movements, flatulence, heartburn, changes in stool color/consistency, vomiting, and gastrointestinal virus.
Frequency: 8 affected / 12 at risk

Adverse event: Infectious
Serious: no
Organ System: Infections and infestations
Notes: Includes common cold, fever, feeling flushed/warm, flu, and hand, foot and mouth.
Frequency: 5 affected / 12 at risk

Adverse event: Muscular
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Includes muscle, joint and bone pain, head shaking, clumsiness, improved motor skills, and tics.
Frequency: 2 affected / 12 at risk

Adverse event: Psychological
Serious: no
Organ System: Psychiatric disorders
Notes: Includes anxiety, aggression, increase in negative behaviors/emotions, confusion/slowed thinking, irritability, changes with speech, better memory, and understanding more.
Frequency: 5 affected / 12 at risk

Adverse event: Genital
Serious: no
Organ System: Renal and urinary disorders
Notes: Includes diurnal enuresis and improved toilet training.
Frequency: 1 affected / 12 at risk

Adverse event: Nose
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Includes nasal/sinus congestion, runny nose, sore throat, strep throat, and tonsillectomy.
Frequency: 5 affected / 12 at risk

Adverse event: Skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 12 at risk

Adverse event: Chest
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Includes allergies, bronchitis, cold symptoms, coughing, and upper respiratory infection.
Frequency: 3 affected / 12 at risk

Adverse event: Energy
Serious: no
Organ System: Nervous system disorders
Notes: Includes overly excited or energetic, calmness, and fatigue.
Frequency: 3 affected / 12 at risk

Adverse event: Sleep
Serious: no
Organ System: Nervous system disorders
Notes: Includes difficulty falling asleep, interrupted sleep, nightmares, drowsiness, and sleeping too much.
Frequency: 4 affected / 12 at risk

Adverse event: Gastrointestinal
Serious: no
Organ System: Gastrointestinal disorders
Notes: Includes changes in appetite, constipation, diarrhea, stomach pain/discomfort, changes in frequency of bowel movements, flatulence, heartburn, changes in stool color/consistency, vomiting, and gastrointestinal virus.
Frequency: 10 affected / 12 at risk

Adverse event: Infectious
Serious: no
Organ System: Infections and infestations
Notes: Includes common cold, fever, feeling flushed/warm, flu, and hand, foot and mouth.
Frequency: 4 affected / 12 at risk

Adverse event: Injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Includes head injury, chin laceration, etc.
Frequency: 1 affected / 12 at risk

Adverse event: Muscular
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Includes muscle, joint and bone pain, head shaking, clumsiness, improved motor skills, and tics.
Frequency: 2 affected / 12 at risk

Adverse event: Psychological
Serious: no
Organ System: Psychiatric disorders
Notes: Includes anxiety, aggression, increase in negative behaviors/emotions, confusion/slowed thinking, irritability, changes with speech, better memory, and understanding more.
Frequency: 4 affected / 12 at risk

Adverse event: Nose
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Includes nasal/sinus congestion, runny nose, sore throat, strep throat, and tonsillectomy.
Frequency: 3 affected / 12 at risk

Adverse event: Skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 12 at risk

Adverse event: Chest
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Includes allergies, bronchitis, cold symptoms, coughing, and upper respiratory infection.
Frequency: 5 affected / 12 at risk

Adverse event: Energy
Serious: no
Organ System: Nervous system disorders
Notes: Includes overly excited or energetic, calmness, and fatigue.
Frequency: 2 affected / 12 at risk

Adverse event: Ear
Serious: no
Organ System: Ear and labyrinth disorders
Notes: Includes ear infection, poor hearing, and fluid in ears.
Frequency: 3 affected / 13 at risk

Adverse event: Eye
Serious: no
Organ System: Eye disorders
Notes: Includes eye irritation and conjunctivitis.
Frequency: 2 affected / 13 at risk

Adverse event: Gastrointestinal
Serious: no
Organ System: Gastrointestinal disorders
Notes: Includes changes in appetite, constipation, diarrhea, stomach pain/discomfort, changes in frequency of bowel movements, flatulence, heartburn, changes in stool color/consistency, vomiting, and gastrointestinal virus.
Frequency: 12 affected / 13 at risk

Adverse event: Infectious
Serious: no
Organ System: Infections and infestations
Notes: Includes common cold, fever, feeling flushed/warm, flu, and hand, foot and mouth.
Frequency: 8 affected / 13 at risk

Adverse event: Injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Includes head injury, chin laceration, etc.
Frequency: 2 affected / 13 at risk

Adverse event: Muscular
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Includes muscle, joint and bone pain, head shaking, clumsiness, improved motor skills, and tics.
Frequency: 1 affected / 13 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 13 at risk

Adverse event: Psychological
Serious: no
Organ System: Psychiatric disorders
Notes: Includes anxiety, aggression, increase in negative behaviors/emotions, confusion/slowed thinking, irritability, changes with speech, better memory, and understanding more.
Frequency: 7 affected / 13 at risk

Adverse event: Genital
Serious: no
Organ System: Renal and urinary disorders
Notes: Includes diurnal enuresis and improved toilet training.
Frequency: 1 affected / 13 at risk

Adverse event: Nose
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Includes nasal/sinus congestion, runny nose, sore throat, strep throat, and tonsillectomy.
Frequency: 4 affected / 13 at risk

Adverse event: Skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 13 at risk

Adverse event: Chest
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Includes allergies, bronchitis, cold symptoms, coughing, and upper respiratory infection.
Frequency: 5 affected / 13 at risk

Adverse event: Sleep
Serious: no
Organ System: Nervous system disorders
Notes: Includes difficulty falling asleep, interrupted sleep, nightmares, drowsiness, and sleeping too much.
Frequency: 2 affected / 13 at risk

Adverse event: Ear
Serious: no
Organ System: Ear and labyrinth disorders
Notes: Includes ear infection, poor hearing, and fluid in ears.
Frequency: 6 affected / 33 at risk

Adverse event: Eye
Serious: no
Organ System: Eye disorders
Notes: Includes eye irritation and conjunctivitis.
Frequency: 2 affected / 33 at risk

Adverse event: Gastrointestinal
Serious: no
Organ System: Gastrointestinal disorders
Notes: Includes changes in appetite, constipation, diarrhea, stomach pain/discomfort, changes in frequency of bowel movements, flatulence, heartburn, changes in stool color/consistency, vomiting, and gastrointestinal virus.
Frequency: 22 affected / 33 at risk

Adverse event: Infectious
Serious: no
Organ System: Infections and infestations
Notes: Includes common cold, fever, feeling flushed/warm, flu, and hand, foot and mouth.
Frequency: 19 affected / 33 at risk

Adverse event: Injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Includes head injury, chin laceration, etc.
Frequency: 2 affected / 33 at risk

Adverse event: Muscular
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Includes muscle, joint and bone pain, head shaking, clumsiness, improved motor skills, and tics.
Frequency: 4 affected / 33 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 33 at risk

Adverse event: Psychological
Serious: no
Organ System: Psychiatric disorders
Notes: Includes anxiety, aggression, increase in negative behaviors/emotions, confusion/slowed thinking, irritability, changes with speech, better memory, and understanding more.
Frequency: 12 affected / 33 at risk

Adverse event: Genital
Serious: no
Organ System: Renal and urinary disorders
Notes: Includes diurnal enuresis and improved toilet training.
Frequency: 1 affected / 33 at risk

Adverse event: Nose
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Includes nasal/sinus congestion, runny nose, sore throat, strep throat, and tonsillectomy.
Frequency: 4 affected / 33 at risk

Adverse event: Skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 33 at risk

Adverse event: Mouth
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Includes teething and jaw pain.
Frequency: 3 affected / 33 at risk

Adverse event: Chest
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Includes allergies, bronchitis, cold symptoms, coughing, and upper respiratory infection.
Frequency: 9 affected / 33 at risk

Adverse event: Energy
Serious: no
Organ System: Nervous system disorders
Notes: Includes overly excited or energetic, calmness, and fatigue.
Frequency: 4 affected / 33 at risk

Adverse event: Sleep
Serious: no
Organ System: Nervous system disorders
Notes: Includes difficulty falling asleep, interrupted sleep, nightmares, drowsiness, and sleeping too much.
Frequency: 6 affected / 33 at risk