Study: NCT03687762

Adverse event: Hospitalization for infection or illness
Serious: yes
Organ System: Infections and infestations
Notes: Not study related
Frequency: 1 affected / 99 at risk

Adverse event: New cancer diagnosis
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Not study related
Frequency: 1 affected / 99 at risk

Adverse event: Hospitalization for surgery or procedure
Serious: yes
Organ System: Surgical and medical procedures
Notes: Not study related
Frequency: 1 affected / 99 at risk

Adverse event: Victim of assault
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Not study related
Frequency: 1 affected / 99 at risk

Adverse event: Hospitalization for mental health disorder
Serious: yes
Organ System: Psychiatric disorders
Notes: Not study related
Frequency: 1 affected / 99 at risk

Adverse event: Skin irritation from ActiGraph wear
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 99 at risk

Adverse event: Non-study related injury/accident
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Not study related
Frequency: 8 affected / 99 at risk

Adverse event: Worsening chronic pain symptoms
Serious: no
Organ System: General disorders
Notes: Not study related
Frequency: 6 affected / 99 at risk

Adverse event: Symptoms of cardiac disorder
Serious: no
Organ System: Cardiac disorders
Notes: Not study related
Frequency: 1 affected / 99 at risk

Adverse event: Migraine or other neurological system symptoms
Serious: no
Organ System: Nervous system disorders
Notes: Not study related
Frequency: 6 affected / 99 at risk

Adverse event: Underwent surgery or a medical procedure
Serious: no
Organ System: Surgical and medical procedures
Notes: Not study related
Frequency: 8 affected / 99 at risk

Adverse event: Symptoms of multiple organ systems
Serious: no
Organ System: General disorders
Notes: Not study related
Frequency: 5 affected / 99 at risk

Adverse event: Symptoms of a vascular disorder
Serious: no
Organ System: Vascular disorders
Notes: Not study related
Frequency: 1 affected / 99 at risk

Adverse event: New/worsening infection
Serious: no
Organ System: Infections and infestations
Notes: Not study related
Frequency: 5 affected / 99 at risk

Adverse event: Symptoms of the GI region
Serious: no
Organ System: Gastrointestinal disorders
Notes: Not study related
Frequency: 5 affected / 99 at risk

Adverse event: Respiratory symptoms/illness
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Not study related
Frequency: 7 affected / 99 at risk

Adverse event: New neoplasm
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Not study related
Frequency: 2 affected / 99 at risk

Adverse event: Experienced allergic reaction
Serious: no
Organ System: Immune system disorders
Notes: Not study related
Frequency: 1 affected / 99 at risk

Adverse event: Symptoms of a blood and lymphatic system disorder
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Not study related
Frequency: 3 affected / 99 at risk

Adverse event: Suicidal ideation
Serious: no
Organ System: Psychiatric disorders
Notes: Not study related
Frequency: 3 affected / 99 at risk

Adverse event: Delusional thinking
Serious: no
Organ System: Psychiatric disorders
Notes: Not study related
Frequency: 1 affected / 99 at risk

Adverse event: Psychological stress due to completing study assessments
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 99 at risk

Adverse event: Victim of assault
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Not study related
Frequency: 1 affected / 99 at risk

Adverse event: Undisclosed reason to ER
Serious: no
Organ System: General disorders
Notes: Not study related
Frequency: 1 affected / 99 at risk

Adverse event: Discomfort from wearing ActiGraph
Serious: no
Organ System: General disorders
Frequency: 2 affected / 99 at risk

Adverse event: Hospitalization for infection or illness
Serious: yes
Organ System: Infections and infestations
Notes: Not study related
Frequency: 1 affected / 102 at risk

Adverse event: Hospitalization for surgery or procedure
Serious: yes
Organ System: Surgical and medical procedures
Notes: Not study related
Frequency: 2 affected / 102 at risk

Adverse event: Hospitalization for cardiac event
Serious: yes
Organ System: Cardiac disorders
Notes: Not study related
Frequency: 2 affected / 102 at risk

Adverse event: Hospitalization for adverse reaction to/complication during medical treatment
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Not study related
Frequency: 1 affected / 102 at risk

Adverse event: Hospitalization for symptoms of unknown cause
Serious: yes
Organ System: General disorders
Notes: Not study related
Frequency: 1 affected / 102 at risk

Adverse event: Hospitalization for pulmonary event
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Not study related
Frequency: 2 affected / 102 at risk

Adverse event: Skin irritation from ActiGraph wear
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 102 at risk

Adverse event: Non-study related injury/accident
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Not study related
Frequency: 10 affected / 102 at risk

Adverse event: Worsening chronic pain symptoms
Serious: no
Organ System: General disorders
Notes: Not study related
Frequency: 5 affected / 102 at risk

Adverse event: Migraine or other neurological system symptoms
Serious: no
Organ System: Nervous system disorders
Notes: Not study related
Frequency: 3 affected / 102 at risk

Adverse event: Underwent surgery or a medical procedure
Serious: no
Organ System: Surgical and medical procedures
Notes: Not study related
Frequency: 10 affected / 102 at risk

Adverse event: Symptoms of multiple organ systems
Serious: no
Organ System: General disorders
Notes: Not study related
Frequency: 3 affected / 102 at risk

Adverse event: New/worsening infection
Serious: no
Organ System: Infections and infestations
Notes: Not study related
Frequency: 4 affected / 102 at risk

Adverse event: Symptoms of the GI region
Serious: no
Organ System: Gastrointestinal disorders
Notes: Not study related
Frequency: 3 affected / 102 at risk

Adverse event: Respiratory symptoms/illness
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Not study related
Frequency: 8 affected / 102 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 / 102 at risk

Adverse event: Psychological stress due to completing study assessments
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 102 at risk

Adverse event: Symptoms of the renal/urinary system
Serious: no
Organ System: Renal and urinary disorders
Notes: Not study related
Frequency: 2 affected / 102 at risk

Adverse event: Symptoms of an immune system disorder
Serious: no
Organ System: Immune system disorders
Notes: Not study related
Frequency: 1 affected / 102 at risk

Adverse event: Symptoms of an ear or labyrinth disorder
Serious: no
Organ System: Ear and labyrinth disorders
Notes: Not study related
Frequency: 1 affected / 102 at risk

Adverse event: Increased depressed mood, anxiety, or PTSD
Serious: no
Organ System: Psychiatric disorders
Notes: Not study related
Frequency: 4 affected / 102 at risk

Adverse event: Discomfort from wearing ActiGraph
Serious: no
Organ System: General disorders
Frequency: 3 affected / 102 at risk

Adverse event: Hospitalization for infection or illness
Serious: yes
Organ System: Infections and infestations
Notes: Not study related
Frequency: 2 affected / 101 at risk

Adverse event: Hospitalization for surgery or procedure
Serious: yes
Organ System: Surgical and medical procedures
Notes: Not study related
Frequency: 2 affected / 101 at risk

Adverse event: Hospitalization for adverse reaction to/complication during medical treatment
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Not study related
Frequency: 2 affected / 101 at risk

Adverse event: Hospitalization for pulmonary event
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Not study related
Frequency: 2 affected / 101 at risk

Adverse event: Hospitalization for increased pain
Serious: yes
Organ System: General disorders
Notes: Not study related
Frequency: 1 affected / 101 at risk

Adverse event: Hospitalization for neurologic event
Serious: yes
Organ System: Nervous system disorders
Notes: Not study related
Frequency: 2 affected / 101 at risk

Adverse event: Skin irritation from ActiGraph wear
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 101 at risk

Adverse event: Non-study related injury/accident
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Not study related
Frequency: 7 affected / 101 at risk

Adverse event: Worsening chronic pain symptoms
Serious: no
Organ System: General disorders
Notes: Not study related
Frequency: 8 affected / 101 at risk

Adverse event: Migraine or other neurological system symptoms
Serious: no
Organ System: Nervous system disorders
Notes: Not study related
Frequency: 6 affected / 101 at risk

Adverse event: Underwent surgery or a medical procedure
Serious: no
Organ System: Surgical and medical procedures
Notes: Not study related
Frequency: 12 affected / 101 at risk

Adverse event: Symptoms of multiple organ systems
Serious: no
Organ System: General disorders
Notes: Not study related
Frequency: 5 affected / 101 at risk

Adverse event: Symptoms of a vascular disorder
Serious: no
Organ System: Vascular disorders
Notes: Not study related
Frequency: 1 affected / 101 at risk

Adverse event: New/worsening infection
Serious: no
Organ System: Infections and infestations
Notes: Not study related
Frequency: 4 affected / 101 at risk

Adverse event: Symptoms of the GI region
Serious: no
Organ System: Gastrointestinal disorders
Notes: Not study related
Frequency: 5 affected / 101 at risk

Adverse event: Respiratory symptoms/illness
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Not study related
Frequency: 12 affected / 101 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 / 101 at risk

Adverse event: Symptoms of a blood and lymphatic system disorder
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Not study related
Frequency: 1 affected / 101 at risk

Adverse event: Psychological stress due to completing study assessments
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 101 at risk

Adverse event: Symptoms of the renal/urinary system
Serious: no
Organ System: Renal and urinary disorders
Notes: Not study related
Frequency: 2 affected / 101 at risk

Adverse event: Increased depressed mood, anxiety, or PTSD
Serious: no
Organ System: Psychiatric disorders
Notes: Not study related
Frequency: 5 affected / 101 at risk

Adverse event: Discomfort from wearing ActiGraph
Serious: no
Organ System: General disorders
Frequency: 2 affected / 101 at risk

Adverse event: Symptoms of an eye disorder
Serious: no
Organ System: Eye disorders
Notes: Not study related
Frequency: 1 affected / 101 at risk