Study: NCT02504151

Adverse event: Hospitalisation
Serious: yes
Organ System: Psychiatric disorders
Notes: Subject experienced a worsening in symptoms
Frequency: 2 affected / 8 at risk

Adverse event: Dry mouth
Serious: no
Organ System: General disorders
Frequency: 1 affected / 8 at risk

Adverse event: Depressed mood, racing thoughts
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 8 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 8 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 8 at risk

Adverse event: ER Visit
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Subject went to ER because of pain from her IUD - was sent home same day and instructed to make an appointment with her OB/GYN
Frequency: 1 affected / 8 at risk

Adverse event: Tension headache
Serious: no
Organ System: General disorders
Frequency: 1 affected / 8 at risk

Adverse event: Migraine
Serious: no
Organ System: General disorders
Frequency: 1 affected / 8 at risk

Adverse event: Sedation
Serious: no
Organ System: General disorders
Notes: Subject was in wash out period, not taking the study medication
Frequency: 1 affected / 8 at risk

Adverse event: Relapse to PCP, LSD, and opiate use
Serious: no
Organ System: General disorders
Frequency: 1 affected / 8 at risk

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 8 at risk

Adverse event: Rash around tattoo
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 8 at risk

Adverse event: Influenza
Serious: no
Organ System: General disorders
Frequency: 1 affected / 8 at risk

Adverse event: Sinusitis
Serious: no
Organ System: General disorders
Frequency: 1 affected / 8 at risk

Adverse event: Dry mouth
Serious: no
Organ System: General disorders
Frequency: 2 affected / 10 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Scratchy throat and cold symptoms
Serious: no
Organ System: General disorders
Frequency: 1 affected / 10 at risk

Adverse event: Stye in left eye
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 10 at risk

Adverse event: Right shin pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 10 at risk

Adverse event: Dermatitis contact
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Occurred after using a new body wash
Frequency: 1 affected / 10 at risk

Adverse event: Increased itchiness of rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Caused by previous condition (COPD)
Frequency: 1 affected / 10 at risk

Adverse event: Increased tiredness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 10 at risk

Adverse event: Pain in right forearm
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 10 at risk

Adverse event: Alcoholic hangover
Serious: no
Organ System: General disorders
Frequency: 1 affected / 10 at risk

Adverse event: Vomitting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: High blood pressure/hospitalization
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 10 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 10 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 10 at risk

Adverse event: Pulled leg muscle
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 10 at risk

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Notes: Nausea/gas
Frequency: 1 affected / 10 at risk

Adverse event: Tingling and numbness on right side to body and face
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 10 at risk

Adverse event: Swollen left foot
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 10 at risk

Adverse event: Worsening of symptoms and more negative affect
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 10 at risk