Study: NCT03169816

Adverse event: Inpatient rehabilitation
Serious: yes
Organ System: General disorders
Notes: Two participants voluntarily entered inpatient rehabilitation programs prior to completing the trial.
Frequency: 2 affected / 33 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 3 affected / 33 at risk

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 33 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: General disorders
Frequency: 2 affected / 33 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 33 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 33 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 2 affected / 33 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 33 at risk

Adverse event: Hot flush
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 33 at risk

Adverse event: Precipitated Withdrawal
Serious: no
Organ System: General disorders
Frequency: 1 affected / 33 at risk

Adverse event: Bachache
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 33 at risk

Adverse event: Dehydration
Serious: no
Organ System: General disorders
Frequency: 1 affected / 33 at risk

Adverse event: Syncope
Serious: no
Organ System: General disorders
Frequency: 1 affected / 33 at risk

Adverse event: Gout
Serious: no
Organ System: General disorders
Frequency: 1 affected / 33 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 1 affected / 33 at risk

Adverse event: Head Sensation
Serious: no
Organ System: General disorders
Frequency: 1 affected / 33 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 1 affected / 33 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: General disorders
Frequency: 1 affected / 33 at risk

Adverse event: Loss of libido
Serious: no
Organ System: General disorders
Frequency: 1 affected / 33 at risk

Adverse event: Sexual dysfunction
Serious: no
Organ System: General disorders
Frequency: 1 affected / 33 at risk

Adverse event: Suicidal ideation
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 33 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 3 affected / 16 at risk

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 16 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: General disorders
Frequency: 2 affected / 16 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 16 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 16 at risk

Adverse event: Precipitated Withdrawal
Serious: no
Organ System: General disorders
Frequency: 1 affected / 16 at risk

Adverse event: Loss of consciousness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 16 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 16 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 16 at risk

Adverse event: Muscle Aches
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 16 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 16 at risk

Adverse event: GI Ulcer
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 16 at risk