Study: NCT03577990

Adverse event: Elevated diastolic blood pressure >110
Serious: yes
Organ System: Vascular disorders
Notes: Hospitalized with diastolic blood pressure \>110. Anti-hypertensive medications re-evaluated and diastolic blood pressure decreased gradually to 90s.
Frequency: 1 affected / 42 at risk

Adverse event: Bunion surgery
Serious: yes
Organ System: Surgical and medical procedures
Notes: Elective Bunion surgery. Participant minimized pre-existing condition when assessing for study eligibility. Uneventful recovery.
Frequency: 1 affected / 42 at risk

Adverse event: Knee arthroplasty
Serious: yes
Organ System: Surgical and medical procedures
Notes: Surgery and hospitalization for total knee replacement due to increased pain. Participant minimized pre-existing condition when assessing for study eligibility. Follow-up with outpatient rehabilitation. Uneventful recovery.
Frequency: 1 affected / 42 at risk

Adverse event: Shoulder arthroplasty
Serious: yes
Organ System: Surgical and medical procedures
Notes: Surgery and hospitalization for shoulder replacement due to increased pain. Participant minimized pre-existing condition when assessing for study eligibility. Follow-up with outpatient rehabilitation. Uneventful recovery.
Frequency: 1 affected / 42 at risk

Adverse event: Neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Breast cancer returned after remission with metastasis. Withdrew from study.
Frequency: 1 affected / 42 at risk

Adverse event: Glaucoma
Serious: yes
Organ System: Surgical and medical procedures
Notes: Outpatient surgery for glaucoma. Participant did not mention this pre-existing condition when assessing for study eligibility. Recovered without incident.
Frequency: 1 affected / 42 at risk

Adverse event: Abdominal pain and bleeding
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Hospitalized for abdominal pain and bleeding. Recovered without incident.
Frequency: 1 affected / 42 at risk

Adverse event: Gastroenteritis viral
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Hospitalized for stomach virus. Recovered without incident.
Frequency: 1 affected / 42 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Treated as an outpatient for pneumonia. Recovered without incident.
Frequency: 1 affected / 42 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Vascular disorders
Notes: Hospitalized with stroke following colonoscopy procedure. Withdrew from study.
Frequency: 1 affected / 41 at risk

Adverse event: Dislodged patella
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Dislodged patella left knee - old injury. Participant minimized this pre-existing condition when assessing for study eligibility. Outpatient treatment, may require surgery.
Frequency: 1 affected / 41 at risk

Adverse event: Twisted ankle
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Twisted ankle and damaged Achilles from fall at work. Treated as outpatient. Recovered without incident.
Frequency: 1 affected / 41 at risk