Study: NCT04409353

Adverse event: Cholelithiasis
Serious: yes
Organ System: Hepatobiliary disorders
Notes: Inpatient hospitalization for cholelithiasis from 12/30/2022 to 1/8/2023 that was unrelated to the intervention. The event was deemed severe, unexpected and was resolved with treatment. The participant discontinued use of the intervention.
Frequency: 1 affected / 127 at risk

Adverse event: Cardiac Arrest and Sepsis
Serious: yes
Organ System: Cardiac disorders
Notes: Cardiac arrest and sepsis from 8/20/2023 to 8/25/2023. Event was unrelated to intervention, unexpected, severe and resolved with treatment. Participant continued to use the intervention.
Frequency: 1 affected / 127 at risk

Adverse event: Cervical fusion
Serious: yes
Organ System: Surgical and medical procedures
Notes: Cervical fusion during the study requiring inpatient rehab hospitalization from 4/17/2023 to 4/27/2023. Event was unrelated to intervention, marked as severe, unexpected and resolved with treatment. Participant continued use of intervention.
Frequency: 1 affected / 127 at risk

Adverse event: Skin Allergic Reaction
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 127 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 127 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 127 at risk

Adverse event: Corneal irritation
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 127 at risk

Adverse event: Cybersickness
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 127 at risk

Adverse event: Neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 127 at risk

Adverse event: Discomfort
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 127 at risk

Adverse event: Dizziness
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 4 affected / 127 at risk

Adverse event: Eye haemorrhage
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 127 at risk

Adverse event: Asthenopia
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 127 at risk

Adverse event: Difficulty Focusing
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 127 at risk

Adverse event: Face Pain
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 127 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 127 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 127 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 127 at risk

Adverse event: Dizziness
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 127 at risk

Adverse event: Motion sickness
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 2 affected / 127 at risk

Adverse event: Skin irritation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 127 at risk

Adverse event: Joint injury
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 127 at risk

Adverse event: Unexpected fall and fever
Serious: yes
Organ System: Infections and infestations
Notes: Participant was hospitalized after fall and fever from 5/6/2021 to 5/8/2021. Event was unrelated to intervention, marked as severe, unexpected and resolved with treatment. Participant continued use of intervention.
Frequency: 1 affected / 127 at risk

Adverse event: Skin Allergic Reaction
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 127 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 127 at risk

Adverse event: Neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 127 at risk

Adverse event: Dizziness
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 2 affected / 127 at risk

Adverse event: Asthenopia
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 127 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 127 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 127 at risk

Adverse event: Heart Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 127 at risk

Adverse event: Migraines
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 127 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 127 at risk

Adverse event: Bacterial infection
Serious: no
Organ System: General disorders
Frequency: 1 affected / 127 at risk

Adverse event: Skin irritation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 127 at risk

Adverse event: Vertigo
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 127 at risk

Adverse event: Localised infection
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: Hospitalization due to bacterial infection of the hand from 3/11/2021 to 3/19/2021. Event was unrelated to the intervention, severe, unexpected and resolved with treatment. Participant continued use of the intervention.
Frequency: 1 affected / 131 at risk

Adverse event: Acute-on-chronic Low Back Pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Participant was hospitalized for intractable, acute-on-chronic low back pain. Event was unrelated to intervention, marked as severe, unexpected and resolved with treatment. Participant continued use of intervention.
Frequency: 1 affected / 131 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Psychiatric disorders
Notes: Participant was hospitalized from 3/17/2023 to 3/23/2023. Event was unrelated to intervention, marked as severe, unexpected and resolved with treatment. Participant continued use of intervention.
Frequency: 1 affected / 131 at risk

Adverse event: Facial Injury Aggravation
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 131 at risk

Adverse event: Skin Allergic Reaction
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 131 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 131 at risk

Adverse event: Cybersickness
Serious: no
Organ System: Product Issues
Frequency: 8 affected / 131 at risk

Adverse event: Neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 8 affected / 131 at risk

Adverse event: Discomfort
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 131 at risk

Adverse event: Dizziness
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 4 affected / 131 at risk

Adverse event: Asthenopia
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 131 at risk

Adverse event: Face Pain
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 131 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 131 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 131 at risk

Adverse event: Insomnia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 131 at risk

Adverse event: Dizziness
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 131 at risk

Adverse event: Migraines
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 131 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 131 at risk

Adverse event: Skin irritation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 131 at risk

Adverse event: Vertigo
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 131 at risk