Study: NCT03521141

Adverse event: Agitation and/or Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 12 affected / 19 at risk

Adverse event: Anger
Serious: no
Organ System: Psychiatric disorders
Frequency: 13 affected / 19 at risk

Adverse event: Depressed mood
Serious: no
Organ System: Psychiatric disorders
Frequency: 11 affected / 19 at risk

Adverse event: Anxiety (includes nervousness and panic attacks)
Serious: no
Organ System: Psychiatric disorders
Frequency: 8 affected / 19 at risk

Adverse event: Restlessness
Serious: no
Organ System: General disorders
Frequency: 10 affected / 19 at risk

Adverse event: Abnormal dreams and/or nightmares
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 19 at risk

Adverse event: Insomnia and/or other sleep
Serious: no
Organ System: Nervous system disorders
Frequency: 12 affected / 19 at risk

Adverse event: Headaches
Serious: no
Organ System: Nervous system disorders
Frequency: 11 affected / 19 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 5 affected / 19 at risk

Adverse event: Nausea and/or vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 19 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 8 affected / 19 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 19 at risk

Adverse event: Hiccups
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 19 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 19 at risk

Adverse event: Throat irritation
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 19 at risk

Adverse event: Other symptom
Serious: no
Organ System: General disorders
Frequency: 5 affected / 19 at risk

Adverse event: Hospitalisation
Serious: no
Organ System: Surgical and medical procedures
Notes: Hospitalizations during the course of the study judged to be unrelated to study procedures
Frequency: 2 affected / 19 at risk

Adverse event: Agitation and/or Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 5 affected / 19 at risk

Adverse event: Anger
Serious: no
Organ System: Psychiatric disorders
Frequency: 5 affected / 19 at risk

Adverse event: Depressed mood
Serious: no
Organ System: Psychiatric disorders
Frequency: 9 affected / 19 at risk

Adverse event: Anxiety (includes nervousness and panic attacks)
Serious: no
Organ System: Psychiatric disorders
Frequency: 7 affected / 19 at risk

Adverse event: Restlessness
Serious: no
Organ System: General disorders
Frequency: 11 affected / 19 at risk

Adverse event: Abnormal dreams and/or nightmares
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 19 at risk

Adverse event: Insomnia and/or other sleep
Serious: no
Organ System: Nervous system disorders
Frequency: 12 affected / 19 at risk

Adverse event: Headaches
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 19 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 4 affected / 19 at risk

Adverse event: Nausea and/or vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 19 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 8 affected / 19 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 19 at risk

Adverse event: Hiccups
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 19 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 10 affected / 19 at risk

Adverse event: Throat irritation
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 19 at risk

Adverse event: Other symptom
Serious: no
Organ System: General disorders
Frequency: 5 affected / 19 at risk

Adverse event: Hospitalisation
Serious: no
Organ System: Surgical and medical procedures
Notes: Hospitalizations during the course of the study judged to be unrelated to study procedures
Frequency: 3 affected / 19 at risk

Adverse event: Agitation and/or Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 12 affected / 20 at risk

Adverse event: Anger
Serious: no
Organ System: Psychiatric disorders
Frequency: 7 affected / 20 at risk

Adverse event: Depressed mood
Serious: no
Organ System: Psychiatric disorders
Frequency: 8 affected / 20 at risk

Adverse event: Anxiety (includes nervousness and panic attacks)
Serious: no
Organ System: Psychiatric disorders
Frequency: 7 affected / 20 at risk

Adverse event: Restlessness
Serious: no
Organ System: General disorders
Frequency: 4 affected / 20 at risk

Adverse event: Abnormal dreams and/or nightmares
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 20 at risk

Adverse event: Insomnia and/or other sleep
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 20 at risk

Adverse event: Headaches
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 20 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 3 affected / 20 at risk

Adverse event: Nausea and/or vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 20 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 6 affected / 20 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 20 at risk

Adverse event: Hiccups
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 20 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 10 affected / 20 at risk

Adverse event: Throat irritation
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 20 at risk

Adverse event: Other symptom
Serious: no
Organ System: General disorders
Frequency: 6 affected / 20 at risk