Study: NCT02158494

Adverse event: General disorders and administration site conditions - Other, specify
Serious: yes
Organ System: General disorders
Notes: Subject became nauseous, with a high fever and impaired balance.Responders brought her to the hospital. She was admitted, assessed and treated. No definite cause for her symptoms was identified. All symptoms have resolved and there was no recurrence.
Frequency: 1 affected / 22 at risk

Adverse event: Gallbladder obstruction
Serious: yes
Organ System: Hepatobiliary disorders
Notes: Subject was admitted to the hospital with abdominal pain and had an ultrasound of his gall bladder that showed gall stones in the gall bladder. He had surgery to remove his gall bladder. He was discharged and was given oxycodone for pain management.
Frequency: 1 affected / 22 at risk

Adverse event: Urinary tract obstruction
Serious: yes
Organ System: Renal and urinary disorders
Notes: Subject reported that he had kidney stones. He was in the hospital for 6 days due to the kidney stones. He went into septic shock. He was treated with IV antibiotics and a stent was placed. Extracorporeal shock wave lithotripsy was scheduled.
Frequency: 1 affected / 22 at risk

Adverse event: General Pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 22 at risk

Adverse event: Musculoskeletal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 22 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 22 at risk

Adverse event: Fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 22 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 22 at risk

Adverse event: Poisoning
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 22 at risk

Adverse event: Surgery
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 22 at risk

Adverse event: Diabetic Shock
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 22 at risk

Adverse event: Vomiting and Diahrrea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 22 at risk

Adverse event: Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 22 at risk

Adverse event: Skin laceration
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 22 at risk

Adverse event: Prostate cancer
Serious: yes
Organ System: Renal and urinary disorders
Notes: During end of study wrap up, subject reported that he had been diagnosed with prostate cancer on 11 Feb 2016. He is under the care of an oncologist and was scheduled for surgery
Frequency: 1 affected / 21 at risk

Adverse event: General Pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 21 at risk

Adverse event: Musculoskeletal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 21 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 21 at risk

Adverse event: Fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 21 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 21 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 21 at risk

Adverse event: Poisoning
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 21 at risk

Adverse event: Surgery
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 21 at risk

Adverse event: Nephrolithiasis
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 21 at risk