Study: NCT03916276

Adverse event: Hospitalization related to new infection/illness
Serious: yes
Organ System: Infections and infestations
Notes: Not study related
Frequency: 1 affected / 31 at risk

Adverse event: Hospitalization due to new/existing respiratory illness
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Not study related
Frequency: 1 affected / 31 at risk

Adverse event: Hospitalization due to new/existing immune system illness
Serious: yes
Organ System: Immune system disorders
Notes: Not study related
Frequency: 1 affected / 31 at risk

Adverse event: Increase in existing chronic pain symptoms related to a study procedure
Serious: no
Organ System: Social circumstances
Frequency: 1 affected / 31 at risk

Adverse event: Increase in pain due to new injury/accident
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Not study related
Frequency: 4 affected / 31 at risk

Adverse event: New/worsening symptoms related to medical procedure/treatment
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Not study related
Frequency: 1 affected / 31 at risk

Adverse event: New/worsening skin irritation/rash related to wearing study ActiGraph device
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 31 at risk

Adverse event: New/worsening respiratory symptoms/illness
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Not study related
Frequency: 4 affected / 31 at risk

Adverse event: New/worsening symptoms related to the endocrine system
Serious: no
Organ System: Endocrine disorders
Notes: Not study related
Frequency: 1 affected / 31 at risk

Adverse event: New/worsening psychological discomfort related to a study procedure
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 31 at risk

Adverse event: New/worsening gastrointestinal symptoms/illness
Serious: no
Organ System: Gastrointestinal disorders
Notes: Not study related
Frequency: 1 affected / 31 at risk

Adverse event: Increase in existing chronic pain symptoms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Not study related
Frequency: 1 affected / 31 at risk

Adverse event: New/worsening sleep problem
Serious: no
Organ System: Nervous system disorders
Notes: Not study related
Frequency: 1 affected / 31 at risk

Adverse event: New/worsening headache/migraine
Serious: no
Organ System: Nervous system disorders
Notes: Not study related
Frequency: 1 affected / 31 at risk

Adverse event: New/worsening symptoms related to multiple organ systems
Serious: no
Organ System: General disorders
Notes: Not study related
Frequency: 1 affected / 31 at risk

Adverse event: New surgery/medical procedure
Serious: no
Organ System: Surgical and medical procedures
Notes: Not study related
Frequency: 1 affected / 31 at risk

Adverse event: Increase in existing chronic pain symptoms related to a study procedure
Serious: no
Organ System: Social circumstances
Frequency: 1 affected / 29 at risk

Adverse event: Increase in pain due to new injury/accident
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Not study related
Frequency: 4 affected / 29 at risk

Adverse event: New/worsening skin irritation/rash related to wearing study ActiGraph device
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 29 at risk

Adverse event: New/worsening respiratory symptoms/illness
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Not study related
Frequency: 3 affected / 29 at risk

Adverse event: New/worsening gastrointestinal symptoms/illness
Serious: no
Organ System: Gastrointestinal disorders
Notes: Not study related
Frequency: 3 affected / 29 at risk

Adverse event: Increase in existing chronic pain symptoms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Not study related
Frequency: 4 affected / 29 at risk

Adverse event: New/worsening sleep problem
Serious: no
Organ System: Nervous system disorders
Notes: Not study related
Frequency: 1 affected / 29 at risk

Adverse event: New/worsening headache/migraine
Serious: no
Organ System: Nervous system disorders
Notes: Not study related
Frequency: 4 affected / 29 at risk

Adverse event: New surgery/medical procedure
Serious: no
Organ System: Surgical and medical procedures
Notes: Not study related
Frequency: 1 affected / 29 at risk

Adverse event: New/worsening infection
Serious: no
Organ System: Infections and infestations
Notes: Not study related
Frequency: 1 affected / 29 at risk

Adverse event: Hospitalization related to new infection/illness
Serious: yes
Organ System: Infections and infestations
Notes: Not study related
Frequency: 1 affected / 31 at risk

Adverse event: Hospitalization due to new/existing respiratory illness
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Not study related
Frequency: 1 affected / 31 at risk

Adverse event: Hospitalization related to a surgery/procedure
Serious: yes
Organ System: Surgical and medical procedures
Notes: Not study related
Frequency: 1 affected / 31 at risk

Adverse event: Hospitalization related to suicidal ideation
Serious: yes
Organ System: Psychiatric disorders
Notes: Not study related
Frequency: 1 affected / 31 at risk

Adverse event: Hospitalization due to illness of multiple organ systems
Serious: yes
Organ System: General disorders
Notes: Not study related
Frequency: 1 affected / 31 at risk

Adverse event: Increase in existing chronic pain symptoms related to a study procedure
Serious: no
Organ System: Social circumstances
Frequency: 2 affected / 31 at risk

Adverse event: Increase in pain due to new injury/accident
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Not study related
Frequency: 5 affected / 31 at risk

Adverse event: New/worsening skin irritation/rash related to wearing study ActiGraph device
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 31 at risk

Adverse event: New/worsening respiratory symptoms/illness
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Not study related
Frequency: 3 affected / 31 at risk

Adverse event: New/worsening gastrointestinal symptoms/illness
Serious: no
Organ System: Gastrointestinal disorders
Notes: Not study related
Frequency: 3 affected / 31 at risk

Adverse event: Increase in existing chronic pain symptoms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Not study related
Frequency: 3 affected / 31 at risk

Adverse event: New/worsening headache/migraine
Serious: no
Organ System: Nervous system disorders
Notes: Not study related
Frequency: 2 affected / 31 at risk

Adverse event: New/worsening symptoms related to multiple organ systems
Serious: no
Organ System: General disorders
Notes: Not study related
Frequency: 1 affected / 31 at risk

Adverse event: New surgery/medical procedure
Serious: no
Organ System: Surgical and medical procedures
Notes: Not study related
Frequency: 1 affected / 31 at risk

Adverse event: New neoplasm
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Not study related
Frequency: 1 affected / 31 at risk

Adverse event: New/worsening urinary illness/infection
Serious: no
Organ System: Renal and urinary disorders
Notes: Not study related
Frequency: 1 affected / 31 at risk

Adverse event: New/worsening kidney related symptoms/illness
Serious: no
Organ System: Renal and urinary disorders
Notes: Not study related
Frequency: 2 affected / 31 at risk

Adverse event: New/worsening neurological symptoms/illness (not migraine)
Serious: no
Organ System: Nervous system disorders
Notes: Not study related
Frequency: 1 affected / 31 at risk

Adverse event: Victim of assault
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Not study related
Frequency: 1 affected / 31 at risk

Adverse event: Adverse reaction related to treatment/medication
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Not study related
Frequency: 1 affected / 31 at risk

Adverse event: New/worsening cardiovascular symptoms/illness
Serious: no
Organ System: Cardiac disorders
Notes: Not study related
Frequency: 1 affected / 31 at risk

Adverse event: New/worsening psychological distress
Serious: no
Organ System: Psychiatric disorders
Notes: Not study related
Frequency: 1 affected / 31 at risk