Study: NCT02418195

Adverse event: worsening depression and SI
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 62 at risk

Adverse event: Suicide attempt
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 62 at risk

Adverse event: altered mental status
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 62 at risk

Adverse event: acute worsening depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 62 at risk

Adverse event: hospitalized-worsening depression and anxiety
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 62 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 13 affected / 62 at risk

Adverse event: Hypoaesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 15 affected / 62 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 62 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 9 affected / 62 at risk

Adverse event: Muscle or joint pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 62 at risk

Adverse event: Myoclonus/muscle twitching
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 62 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: General disorders
Frequency: 1 affected / 62 at risk

Adverse event: Paranoia
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 62 at risk

Adverse event: Parasthesia/tingling
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 62 at risk

Adverse event: Phantosmia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 62 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 62 at risk

Adverse event: Restlessness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 62 at risk

Adverse event: Sedation
Serious: no
Organ System: General disorders
Frequency: 1 affected / 62 at risk

Adverse event: Sensation needing to urinate
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 62 at risk

Adverse event: Skin fissures
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 62 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 62 at risk

Adverse event: Visual impairment
Serious: no
Organ System: Eye disorders
Frequency: 13 affected / 62 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 62 at risk

Adverse event: Aphasia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 62 at risk

Adverse event: Ataxia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 62 at risk

Adverse event: Auditory disturbance
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 5 affected / 62 at risk

Adverse event: Cardiovascular disturbance
Serious: no
Organ System: Cardiac disorders
Frequency: 5 affected / 62 at risk

Adverse event: Crying, tearfulness
Serious: no
Organ System: General disorders
Frequency: 2 affected / 62 at risk

Adverse event: Difficulty concentrating
Serious: no
Organ System: General disorders
Frequency: 6 affected / 62 at risk

Adverse event: Dissociation
Serious: no
Organ System: Psychiatric disorders
Frequency: 15 affected / 62 at risk

Adverse event: Drowsiness,fatigue
Serious: no
Organ System: General disorders
Frequency: 14 affected / 62 at risk

Adverse event: Dry mouth
Serious: no
Organ System: General disorders
Frequency: 3 affected / 62 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: General disorders
Frequency: 7 affected / 62 at risk

Adverse event: Fall
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 62 at risk

Adverse event: Gastrointestinal disorder
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 62 at risk

Adverse event: Hallucination
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 62 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 3 affected / 62 at risk

Adverse event: Hypomania
Serious: no
Organ System: Psychiatric disorders
Frequency: 15 affected / 62 at risk

Adverse event: Hot flash
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 62 at risk

Adverse event: hospitalized-depression,anxiety, chronic pain
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 63 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 13 affected / 63 at risk

Adverse event: Hypoaesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 16 affected / 63 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 63 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 3 affected / 63 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 9 affected / 63 at risk

Adverse event: Muscle or joint pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 63 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: General disorders
Frequency: 2 affected / 63 at risk

Adverse event: Paranoia
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 63 at risk

Adverse event: Parasthesia/tingling
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 63 at risk

Adverse event: Phantosmia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 63 at risk

Adverse event: Restlessness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 63 at risk

Adverse event: Sedation
Serious: no
Organ System: General disorders
Frequency: 4 affected / 63 at risk

Adverse event: Sensation needing to urinate
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 63 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 63 at risk

Adverse event: Swelling in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 63 at risk

Adverse event: Tremor
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 63 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 63 at risk

Adverse event: Visual impairment
Serious: no
Organ System: Eye disorders
Frequency: 9 affected / 63 at risk

Adverse event: Acne
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 63 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 9 affected / 63 at risk

Adverse event: Apathy
Serious: no
Organ System: General disorders
Frequency: 1 affected / 63 at risk

Adverse event: Aphasia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 63 at risk

Adverse event: Ataxia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 7 affected / 63 at risk

Adverse event: Auditory disturbance
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 3 affected / 63 at risk

Adverse event: Cardiovascular disturbance
Serious: no
Organ System: Cardiac disorders
Frequency: 5 affected / 63 at risk

Adverse event: Crying, tearfulness
Serious: no
Organ System: General disorders
Frequency: 3 affected / 63 at risk

Adverse event: Difficulty concentrating
Serious: no
Organ System: General disorders
Frequency: 5 affected / 63 at risk

Adverse event: Dissociation
Serious: no
Organ System: Psychiatric disorders
Frequency: 21 affected / 63 at risk

Adverse event: Drowsiness,fatigue
Serious: no
Organ System: General disorders
Frequency: 17 affected / 63 at risk

Adverse event: Dry mouth
Serious: no
Organ System: General disorders
Frequency: 9 affected / 63 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: General disorders
Frequency: 4 affected / 63 at risk

Adverse event: Flushing
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 63 at risk

Adverse event: Gastrointestinal disorder
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 63 at risk

Adverse event: Hallucination
Serious: no
Organ System: Psychiatric disorders
Frequency: 6 affected / 63 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 6 affected / 63 at risk

Adverse event: Hypomania
Serious: no
Organ System: Psychiatric disorders
Frequency: 10 affected / 63 at risk

Adverse event: Hot flash
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 63 at risk

Adverse event: elevated blood pressure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 61 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 16 affected / 61 at risk

Adverse event: Hypoaesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 20 affected / 61 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 7 affected / 61 at risk

Adverse event: Muscle or joint pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 61 at risk

Adverse event: Paranoia
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 61 at risk

Adverse event: Parasthesia/tingling
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 61 at risk

Adverse event: Phantosmia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 61 at risk

Adverse event: Sedation
Serious: no
Organ System: General disorders
Frequency: 3 affected / 61 at risk

Adverse event: Single nightmare
Serious: no
Organ System: General disorders
Frequency: 1 affected / 61 at risk

Adverse event: Toothache
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 61 at risk

Adverse event: Visual impairment
Serious: no
Organ System: Eye disorders
Frequency: 10 affected / 61 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 5 affected / 61 at risk

Adverse event: Aphasia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 61 at risk

Adverse event: Ataxia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 61 at risk

Adverse event: Auditory disturbance
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 5 affected / 61 at risk

Adverse event: Cardiovascular disturbance
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 61 at risk

Adverse event: Cold flash
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 61 at risk

Adverse event: Crying, tearfulness
Serious: no
Organ System: General disorders
Frequency: 3 affected / 61 at risk

Adverse event: Difficulty concentrating
Serious: no
Organ System: General disorders
Frequency: 7 affected / 61 at risk

Adverse event: Dissociation
Serious: no
Organ System: Psychiatric disorders
Frequency: 20 affected / 61 at risk

Adverse event: Drowsiness,fatigue
Serious: no
Organ System: General disorders
Frequency: 19 affected / 61 at risk

Adverse event: Dry mouth
Serious: no
Organ System: General disorders
Frequency: 4 affected / 61 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 61 at risk

Adverse event: Flushing
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 61 at risk

Adverse event: Gastrointestinal disorder
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 61 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 6 affected / 61 at risk

Adverse event: Hypomania
Serious: no
Organ System: Psychiatric disorders
Frequency: 5 affected / 61 at risk

Adverse event: Hot flash
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 61 at risk

Adverse event: Cardiovascular disturbance
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 61 at risk