Study: NCT03683394

Adverse event: Hospitalizations
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 82 at risk

Adverse event: Hospitalizations
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 82 at risk

Adverse event: Hospitalizations
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 82 at risk

Adverse event: Hospitalizations
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 82 at risk

Adverse event: Hospitalizations
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 82 at risk

Adverse event: Hospitalizations
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 82 at risk

Adverse event: Hospitalizations
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 82 at risk

Adverse event: Hospitalizations
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 82 at risk

Adverse event: Hospitalizations
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 82 at risk

Adverse event: Hospitalizations
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 2 affected / 82 at risk

Adverse event: Life-Threatening Event
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 82 at risk

Adverse event: Non-Serious, Possibly Related
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Calf cramps, joint pain, muscle pulls
Frequency: 9 affected / 82 at risk

Adverse event: Non-Serious, Possibly Related
Serious: no
Organ System: Psychiatric disorders
Notes: Study-related anxiety
Frequency: 2 affected / 82 at risk

Adverse event: Non-Serious, Possibly Related
Serious: no
Organ System: Cardiac disorders
Notes: High blood pressure at study visit
Frequency: 2 affected / 82 at risk

Adverse event: Non-serious, Possibly Related
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Rash from activity monitor
Frequency: 1 affected / 82 at risk

Adverse event: Hospitalizations
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 90 at risk

Adverse event: Hospitalizations
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 90 at risk

Adverse event: Hospitalizations
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 90 at risk

Adverse event: Hospitalizations
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 90 at risk

Adverse event: Hospitalizations
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 90 at risk

Adverse event: Life-Threatening Event
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 90 at risk

Adverse event: Hospitalizations
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 90 at risk

Adverse event: Hospitalizations
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 90 at risk

Adverse event: Hospitalizations
Serious: yes
Organ System: Vascular disorders
Frequency: 5 affected / 90 at risk

Adverse event: Life-Threatening Event
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 90 at risk