Study: NCT01757301

Adverse event: Endorsed Suicidal Thoughts
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 147 at risk

Adverse event: Hospitalization for pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 147 at risk

Adverse event: Hospitalization for Influenza
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 147 at risk

Adverse event: Hospitalization for kidney stone
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 147 at risk

Adverse event: Broken kneecap
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Kneecap broken after falling on ice. Received urgent treatment at local hospital and scheduled surgery to repair.
Frequency: 1 affected / 147 at risk

Adverse event: Hospitalization for TIA
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 147 at risk

Adverse event: Hospitalization for wound
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 147 at risk

Adverse event: Hospitalization for planned knee replacement
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 147 at risk

Adverse event: Hospitalization for planned angioplasty
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 147 at risk

Adverse event: Hospitalization for heart catheterization
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 147 at risk

Adverse event: Hospitalization for thyroidectomy
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 147 at risk

Adverse event: Hospitalization for planned hip surgery
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 147 at risk

Adverse event: Hospitalization for planned hernia repair
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 2 affected / 147 at risk

Adverse event: Hospitalization following fall from ladder
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Hospitalized for pain control following fall from 10 foot ladder. Suffered several broken ribs.
Frequency: 1 affected / 147 at risk

Adverse event: ER visit for trouble breathing
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 147 at risk

Adverse event: Surgery following dog attack injuries
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 147 at risk

Adverse event: Hospitalization for infection
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 147 at risk

Adverse event: Hospitalization following amputation of left leg
Serious: yes
Organ System: Infections and infestations
Notes: Participant had calcaneus removed which resulted in a bone infection. Left leg amputated as a result.
Frequency: 1 affected / 147 at risk

Adverse event: Triggered Suicidal Ideation Screener
Serious: no
Organ System: Psychiatric disorders
Notes: Responses were recorded as Adverse Events when participants responded Somewhat/Very Likely, or refused to answer how likely they were to act on their self-harm thoughts and/or if they reported nothing/no one to prevent them from self-harm.
Frequency: 13 affected / 147 at risk

Adverse event: Hospitalization for Suicidal Behavior
Serious: yes
Organ System: Psychiatric disorders
Frequency: 4 affected / 147 at risk

Adverse event: Hospitalization for pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 147 at risk

Adverse event: Hospitalization for TIA
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 147 at risk

Adverse event: Hospitalization for wound
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 147 at risk

Adverse event: Hospitalization for planned hip surgery
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 147 at risk

Adverse event: Hospitalization for planned hernia repair
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 147 at risk

Adverse event: Hospitalization following emergency appendectomy
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 147 at risk

Adverse event: Hospitalization for diverticulitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 147 at risk

Adverse event: Hospitalization for gastroparesis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 147 at risk

Adverse event: Hospitalization for planned autologous fascial sling surgery
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 147 at risk

Adverse event: Diagnosis of Hodgkins Lymphoma
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Diagnosis made by GI following biopsy of lymph node during endoscopic ultrasound procedure.
Frequency: 1 affected / 147 at risk

Adverse event: ER visit for atypical chest pain
Serious: yes
Organ System: Cardiac disorders
Notes: Presented to ER with atypical chest pain. Normal evaluation and work up. Released in stable condition.
Frequency: 2 affected / 147 at risk

Adverse event: Hospitalization for planned septoplasty
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 2 affected / 147 at risk

Adverse event: Hospitalization for substance abuse
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 147 at risk

Adverse event: Hospitalization following renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 147 at risk

Adverse event: Diagnosis of deep vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 147 at risk

Adverse event: ER visit for fall
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 147 at risk

Adverse event: Yearly surveillance for known prostate cancer
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 147 at risk

Adverse event: Hospitalization for heart stent placement
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 147 at risk

Adverse event: Hospitalization following elective laminectomy/fusion
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 147 at risk

Adverse event: Hospitalization for polycythemia likely secondary to renal mass
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 147 at risk

Adverse event: Hospitalization for pneumonitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 147 at risk

Adverse event: Hospitalization for infection
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 147 at risk

Adverse event: Hospitalized following stem cell transplant
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 147 at risk

Adverse event: Hospitalization for COPD
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 147 at risk

Adverse event: Hospitalization for bronchitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 147 at risk

Adverse event: Hospitalization for pulmonary edema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 147 at risk

Adverse event: Hospitalization for atypical chest pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 147 at risk

Adverse event: Hospitalization for collapsed lung
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 147 at risk

Adverse event: Triggered Suicidal Ideation Screener
Serious: no
Organ System: Psychiatric disorders
Notes: Responses were recorded as Adverse Events when participants responded Somewhat/Very Likely, or refused to answer how likely they were to act on their self-harm thoughts and/or if they reported nothing/no one to prevent them from self-harm.
Frequency: 16 affected / 147 at risk

Adverse event: Known medication side effects
Serious: no
Organ System: General disorders
Frequency: 61 affected / 147 at risk