Study: NCT02161133

Adverse event: ER visit
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 135 at risk

Adverse event: ER Visit
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 135 at risk

Adverse event: Admitted to hospital for numbness in arm
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 135 at risk

Adverse event: Admitted to hospital for pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 135 at risk

Adverse event: Emotional difficulty during QI. Nighmares after Baseline Visit.
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 135 at risk

Adverse event: Hospitalized for abdominal pain; Dx with hernia and discharged 3 days after
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 135 at risk

Adverse event: Increased depression and Suicidal Ideation. Has chronic SI.
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 135 at risk

Adverse event: Cataract surgery; overnight stay. Increased dizziness.
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 135 at risk

Adverse event: Increased headaches; previous unreported passive SI when experience headache episode.
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 135 at risk

Adverse event: Dx with Kidney cancer; operation to remove cancer - hospitalized 2 days.
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 135 at risk

Adverse event: Hip replacement and diagnosed with heart disease approx. 1 month after hip replacement
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 135 at risk

Adverse event: Right nephrectomy due to mass found in kidney. Hospitalized for 2 days and discharged.
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 135 at risk

Adverse event: ER Visit
Serious: yes
Organ System: Social circumstances
Frequency: 6 affected / 135 at risk

Adverse event: distressing memories
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 135 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 135 at risk

Adverse event: Hand numbness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 135 at risk

Adverse event: Heartburn, vertigo
Serious: no
Organ System: General disorders
Frequency: 1 affected / 135 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Frequency: 1 affected / 135 at risk

Adverse event: Cramping L hand and R foot
Serious: no
Organ System: General disorders
Frequency: 1 affected / 135 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 135 at risk

Adverse event: Rash on left ear
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 135 at risk

Adverse event: Recurrence of IBS
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 135 at risk

Adverse event: Pain up R arm and hand
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 135 at risk

Adverse event: Increased frequency of nightmares as a result of increasing social activities
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 135 at risk

Adverse event: Thrown out back from building shelves and drawers.
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 135 at risk

Adverse event: Increasing arthritis pain in foot since car accident 3 months ago.
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 135 at risk

Adverse event: ER Visit
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 135 at risk

Adverse event: Passive SI without intent or plan.
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 135 at risk

Adverse event: increasing emotionally labile, tearful, disorganized thinking
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 133 at risk

Adverse event: increased nightmares
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 133 at risk

Adverse event: ER visit
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 133 at risk

Adverse event: ER Visit
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 133 at risk

Adverse event: Admitted to hospital for severe abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 133 at risk

Adverse event: Scheduled plastic surgery
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 133 at risk

Adverse event: ER Visit
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 133 at risk

Adverse event: ER Visit
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 133 at risk

Adverse event: Kidney removed; no chemo or radiation at this time
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 133 at risk

Adverse event: Unplanned surgery for intestinal blockage.
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 133 at risk

Adverse event: Overwhelmed from reflecting about GWI Sx. Felt better after journaling.
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 133 at risk

Adverse event: Admitted to hospital for passing out on motorcycle.
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 133 at risk

Adverse event: Hospitalized for same day posterior cervical laminectomy surgery.
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 133 at risk

Adverse event: Hospital same day surgery for cyst removal from lower back.
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 133 at risk

Adverse event: Increase in intensity of suicidal ideation without intent. Has a history of SI.
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 133 at risk

Adverse event: ER Visit
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 133 at risk

Adverse event: Hysterectomy surgery and overnight stay at hospital. ER on different day for abnormal amount of blee
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 133 at risk

Adverse event: Increased suicidal ideation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 133 at risk

Adverse event: ER Visit
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 133 at risk

Adverse event: ER Visit
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 133 at risk

Adverse event: Chest spasms
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 133 at risk

Adverse event: Foot issue
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 133 at risk

Adverse event: Sinusitis/bronchitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 133 at risk

Adverse event: Herniated disk
Serious: no
Organ System: General disorders
Frequency: 1 affected / 133 at risk

Adverse event: Extreme pain and heat in body
Serious: no
Organ System: General disorders
Frequency: 1 affected / 133 at risk

Adverse event: Rash on face, affecting eyes
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 133 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 133 at risk

Adverse event: Left shoulder pain
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 133 at risk

Adverse event: Infectious mononucleosis
Serious: no
Organ System: Social circumstances
Frequency: 1 affected / 133 at risk

Adverse event: Trouble with memory - signing name
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 133 at risk

Adverse event: Torn bicep muscle playing ball
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 133 at risk

Adverse event: Increased pain and sciatica due to increased exercise on treadmill/stationary bike.
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 133 at risk

Adverse event: Increased frequency of nightmares to 1/week from 3-4 times/year.
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 133 at risk

Adverse event: PTSD symptoms
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 133 at risk