Study: NCT02233413

Adverse event: Subdural haematoma
Serious: yes
Organ System: Nervous system disorders
Notes: Severe, expected, unrelated. During data review a SDH was discovered on study MRI which was not present on clinical CT.
Frequency: 1 affected / 31 at risk

Adverse event: Pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Severe, unexpected, unrelated. Subject came back to hospital due to pancreatitis
Frequency: 1 affected / 31 at risk

Adverse event: MSSA bacteremia
Serious: yes
Organ System: Infections and infestations
Notes: Severe, unexpected, unrelated. Subject went back to hospital due to MSSA bacteremia
Frequency: 1 affected / 31 at risk

Adverse event: Hospital visit due to headache
Serious: yes
Organ System: Nervous system disorders
Notes: Severe, expected, unrelated.
Frequency: 3 affected / 31 at risk

Adverse event: Suicidal ideation
Serious: yes
Organ System: Psychiatric disorders
Notes: Severe, unexpected, unrelated. Subject went back to hospital due to suicidal ideation in the setting of intermittent depressive symptoms over years, chronic pain, and other difficulties. Evaluated and cleared by psychiatry.
Frequency: 1 affected / 31 at risk

Adverse event: Rectal foreign body
Serious: yes
Organ System: Surgical and medical procedures
Notes: Severe, unexpected, unrelated. Subject went back to hospital due to rectal foreign body
Frequency: 1 affected / 31 at risk

Adverse event: Symptom reporting
Serious: no
Organ System: Nervous system disorders
Notes: Reporting of one or more of the following: Headache, blurred vision, double vision, dizziness, numbness, NV, ringing, noise, light, forgetfulness, thinking, concentrating, irritable, frustrated, restless, sleeping, fatigue, depressed.
Frequency: 13 affected / 31 at risk

Adverse event: Glass from motor vehicle accident removed
Serious: no
Organ System: Surgical and medical procedures
Notes: Subject went back to hospital to have glass from motor vehicle accident removed from skin on forehead.
Frequency: 1 affected / 31 at risk

Adverse event: Craniofacial fracture
Serious: no
Organ System: Surgical and medical procedures
Notes: Subject went back to hospital to have broken nose corrected.
Frequency: 1 affected / 31 at risk

Adverse event: Fracture treatment
Serious: no
Organ System: Surgical and medical procedures
Notes: Subject went back to hospital for repair of zygomaticomaxillary complex (ZMC) and orbital floor fractures.
Frequency: 1 affected / 31 at risk

Adverse event: Musculoskeletal neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Subject went back to hospital due to neck pain.
Frequency: 1 affected / 31 at risk

Adverse event: Fall
Serious: no
Organ System: Social circumstances
Notes: Subject went back to hospital due to fall
Frequency: 1 affected / 31 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Notes: Subject went back to hospital due to dizziness
Frequency: 1 affected / 31 at risk

Adverse event: Ligament sprain
Serious: no
Organ System: Surgical and medical procedures
Notes: Subject returned to hospital due to motor vehicle accident with diagnosis of shoulder sprain
Frequency: 1 affected / 31 at risk

Adverse event: Operation for tibial & fibular fracture
Serious: yes
Organ System: Surgical and medical procedures
Notes: Severe, unexpected, unrelated. Subject came back for scheduled operation due to nonunion left distal tibial \& fibular fracture
Frequency: 1 affected / 28 at risk

Adverse event: Pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Severe, unexpected, unrelated. Subject came back to hospital due to pancreatitis
Frequency: 1 affected / 28 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Severe, unexpected, unrelated. Subject went back to hospital due to COPD exacerbation.
Frequency: 1 affected / 28 at risk

Adverse event: Cystitis haemorrhagic
Serious: yes
Organ System: Renal and urinary disorders
Notes: Severe, unexpected, unrelated. Subject went back to hospital due to hemorrhagic cystitis.
Frequency: 1 affected / 28 at risk

Adverse event: Symptom reporting
Serious: no
Organ System: Nervous system disorders
Notes: Reporting of one or more of the following: Headache, blurred vision, double vision, dizziness, numbness, NV, ringing, noise, light, forgetfulness, thinking, concentrating, irritable, frustrated, restless, sleeping, fatigue, depressed.
Frequency: 10 affected / 28 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Subject visited urgent care for persistent cough
Frequency: 1 affected / 28 at risk

Adverse event: Numbness/tingling in toes
Serious: no
Organ System: Nervous system disorders
Notes: Subject reported numbness/tingling in toes 1 week to 3 month time point
Frequency: 1 affected / 28 at risk

Adverse event: Alcohol abuse
Serious: no
Organ System: Social circumstances
Notes: Subject went back to hospital due to alcohol abuse/intoxication.
Frequency: 1 affected / 28 at risk

Adverse event: Joint dislocation
Serious: no
Organ System: Surgical and medical procedures
Notes: Subject went back to hospital for dislocated shoulder
Frequency: 1 affected / 28 at risk

Adverse event: Cataract surgery
Serious: no
Organ System: Eye disorders
Notes: Subject went back to hospital for cataract surgery
Frequency: 1 affected / 28 at risk

Adverse event: Ligament sprain
Serious: no
Organ System: Surgical and medical procedures
Notes: Subject returned to hospital due to motor vehicle accident with diagnosis of shoulder sprain
Frequency: 1 affected / 28 at risk

Adverse event: Haemorrhagic cyst
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Hemorrhagic cyst
Frequency: 1 affected / 28 at risk