Study: NCT02400736

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Notes: Hospitalized for Seizures
Frequency: 1 affected / 58 at risk

Adverse event: Suicidal ideation
Serious: yes
Organ System: Psychiatric disorders
Notes: Hospitalized for suicidal ideation and depression.
Frequency: 2 affected / 58 at risk

Adverse event: Nephrolithiasis
Serious: yes
Organ System: Renal and urinary disorders
Notes: Hospitalize due to pain from kidney stone
Frequency: 1 affected / 58 at risk

Adverse event: Gun shot wound
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: Hospitalized for observation.
Frequency: 1 affected / 58 at risk

Adverse event: Death
Serious: yes
Organ System: Cardiac disorders
Notes: Death due to myocardial infarction
Frequency: 1 affected / 58 at risk

Adverse event: Chest pain
Serious: yes
Organ System: Cardiac disorders
Notes: hospitalized due to chest pain
Frequency: 1 affected / 58 at risk

Adverse event: Muscular Skeletal Pain or Problem
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 8 affected / 58 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Notes: Viral an/d bacterial
Frequency: 3 affected / 58 at risk

Adverse event: Mental health
Serious: no
Organ System: Psychiatric disorders
Notes: mental health or substance use
Frequency: 2 affected / 58 at risk

Adverse event: Eye
Serious: no
Organ System: Eye disorders
Notes: Problems pertaining to eye.
Frequency: 1 affected / 58 at risk

Adverse event: Neurological
Serious: no
Organ System: Nervous system disorders
Notes: Headache, spinal disc problem, or Seizure
Frequency: 2 affected / 58 at risk

Adverse event: Cardiovascular
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 58 at risk

Adverse event: Reproductive system
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 58 at risk

Adverse event: GI, including dental
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 58 at risk

Adverse event: Ear
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 58 at risk

Adverse event: Accidents, insects, dog bites
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 58 at risk

Adverse event: Suicidal ideation
Serious: yes
Organ System: Psychiatric disorders
Notes: Hospitalized for suicidal ideation and depression.
Frequency: 1 affected / 61 at risk

Adverse event: Peptic ulcer
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Hospitalized for chest pain but determined cause was acid reflux and peptic ulcer
Frequency: 1 affected / 61 at risk

Adverse event: Neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Hospitalized for prostate cancer
Frequency: 1 affected / 61 at risk

Adverse event: Hysterectomy
Serious: yes
Organ System: Reproductive system and breast disorders
Notes: Hospitalized for hysterectomy
Frequency: 1 affected / 61 at risk

Adverse event: Muscular Skeletal Pain or Problem
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 9 affected / 61 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Notes: Viral an/d bacterial
Frequency: 6 affected / 61 at risk

Adverse event: Mental health
Serious: no
Organ System: Psychiatric disorders
Notes: mental health or substance use
Frequency: 1 affected / 61 at risk

Adverse event: Eye
Serious: no
Organ System: Eye disorders
Notes: Problems pertaining to eye.
Frequency: 1 affected / 61 at risk

Adverse event: Neurological
Serious: no
Organ System: Nervous system disorders
Notes: Headache, spinal disc problem, or Seizure
Frequency: 4 affected / 61 at risk

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

Adverse event: Reproductive system
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 61 at risk

Adverse event: GI, including dental
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 61 at risk

Adverse event: Pmonary
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 61 at risk

Adverse event: Accidents, insects, dog bites
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 61 at risk

Adverse event: Diabetes mellitus
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 61 at risk