Study: NCT02966873

Adverse event: Injury/Accident
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Hospitalization from injury/accident.
Frequency: 1 affected / 93 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Pneumonia - hospitalized
Frequency: 2 affected / 93 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 93 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 93 at risk

Adverse event: Pancreatitis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 93 at risk

Adverse event: Cystitis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 93 at risk

Adverse event: Anxiety
Serious: no
Organ System: Nervous system disorders
Notes: Anxiety Anxiety or Panic Attack Anxiety, worsening
Frequency: 2 affected / 93 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: Constipation
Frequency: 2 affected / 93 at risk

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Notes: Gastrointestinal Discomfort, non-specified
Frequency: 21 affected / 93 at risk

Adverse event: Headache/Migraine
Serious: no
Organ System: Nervous system disorders
Notes: Headache (including worsening) Migraine(including worsening)
Frequency: 4 affected / 93 at risk

Adverse event: Injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: injury: abscess on hand wound post surgery Injury: back injury from work injury: broken toe (pinky, left foot) Injury: broken tooth injury: infection in hand post-surgery injury: knee injury injury: sprained ankle
Frequency: 9 affected / 93 at risk

Adverse event: Muscle or Joint Pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Muscle or Joint Pain (neck, back, wrist, rib, side, led)
Frequency: 7 affected / 93 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 93 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Notes: Sinusitis
Frequency: 3 affected / 93 at risk

Adverse event: Viral Upper Respiratory Tract Infections (Cold)
Serious: no
Organ System: Infections and infestations
Notes: Viral Upper Respiratory Tract Infections (Cold)
Frequency: 15 affected / 93 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Notes: Flatulence
Frequency: 5 affected / 93 at risk

Adverse event: Injury/Accident
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Hospitalization from injury/accident.
Frequency: 1 affected / 89 at risk

Adverse event: Ectopic Pregnancy & Ruptured Fallopian Tube
Serious: yes
Organ System: Reproductive system and breast disorders
Notes: Surgical procedure to repair ruptured fallopian tube (complication from ectopic pregnancy). Participant was hospitalized.
Frequency: 1 affected / 89 at risk

Adverse event: Suicidal ideation
Serious: yes
Organ System: Psychiatric disorders
Notes: Suicidal Ideation - Hospitalization
Frequency: 1 affected / 89 at risk

Adverse event: Anxiety
Serious: no
Organ System: Nervous system disorders
Notes: Anxiety Anxiety or Panic Attack Anxiety, worsening
Frequency: 7 affected / 89 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: Constipation
Frequency: 4 affected / 89 at risk

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Notes: Gastrointestinal Discomfort, non-specified
Frequency: 9 affected / 89 at risk

Adverse event: Headache/Migraine
Serious: no
Organ System: Nervous system disorders
Notes: Headache (including worsening) Migraine(including worsening)
Frequency: 13 affected / 89 at risk

Adverse event: Injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: injury: abscess on hand wound post surgery Injury: back injury from work injury: broken toe (pinky, left foot) Injury: broken tooth injury: infection in hand post-surgery injury: knee injury injury: sprained ankle
Frequency: 8 affected / 89 at risk

Adverse event: Muscle or Joint Pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Muscle or Joint Pain (neck, back, wrist, rib, side, led)
Frequency: 10 affected / 89 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 89 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Notes: Sinusitis
Frequency: 6 affected / 89 at risk

Adverse event: Viral Upper Respiratory Tract Infections (Cold)
Serious: no
Organ System: Infections and infestations
Notes: Viral Upper Respiratory Tract Infections (Cold)
Frequency: 14 affected / 89 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Notes: Flatulence
Frequency: 2 affected / 89 at risk