Study: NCT03812614

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Abdominal pain and/or vomiting requiring hospital admission. Unrelated to study participation.
Frequency: 1 affected / 112 at risk

Adverse event: Blood clot
Serious: yes
Organ System: Vascular disorders
Notes: Blood clot requiring hospital admission. Unrelated to study participation.
Frequency: 1 affected / 112 at risk

Adverse event: COVID-19 complications
Serious: yes
Organ System: Infections and infestations
Notes: COVID-19 complications requiring hospital admission. Unrelated to study participation.
Frequency: 2 affected / 112 at risk

Adverse event: Hospital admission, unspecified
Serious: yes
Organ System: General disorders
Notes: Hospital admission unrelated to study participation with no additional information.
Frequency: 14 affected / 112 at risk

Adverse event: COVID-19
Serious: no
Organ System: Infections and infestations
Notes: Tested positive for COVID-19. Unrelated to study participation.
Frequency: 8 affected / 112 at risk

Adverse event: Injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Patient 1, finger laceration; patient 2, foot laceration; patient 3, puncture wound to foot; patient 4, fall. All resulted in a visit to a hospital emergency department without inpatient admission. None related to study participation.
Frequency: 3 affected / 112 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Shortness of breath resulting in a visit to a hospital emergency department. No inpatient admission. Unrelated to study participation.
Frequency: 1 affected / 112 at risk

Adverse event: Fibromyalgia pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Exacerbation of existing fibromyalgia pain resulting in a visit to a hospital emergency department. No inpatient admission. Unrelated to study participation.
Frequency: 1 affected / 112 at risk

Adverse event: Emergency department, unspecified
Serious: no
Organ System: General disorders
Notes: Unspecified events resulting in a visit to a hospital emergency department without inpatient admission. Unrelated to study participation.
Frequency: 25 affected / 112 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Abdominal pain and/or vomiting requiring hospital admission. Unrelated to study participation.
Frequency: 1 affected / 110 at risk

Adverse event: Pulmonary emphysema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Pulmonary emphysema exacerbation requiring hospital admission. Unrelated to study participation.
Frequency: 1 affected / 110 at risk

Adverse event: Renal pain
Serious: yes
Organ System: Renal and urinary disorders
Notes: Kidney pain requiring hospital admission. Unrelated to study participation.
Frequency: 1 affected / 110 at risk

Adverse event: Hospital admission, unspecified
Serious: yes
Organ System: General disorders
Notes: Hospital admission unrelated to study participation with no additional information.
Frequency: 17 affected / 110 at risk

Adverse event: COVID-19
Serious: no
Organ System: Infections and infestations
Notes: Tested positive for COVID-19. Unrelated to study participation.
Frequency: 7 affected / 110 at risk

Adverse event: Injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Patient 1, finger laceration; patient 2, foot laceration; patient 3, puncture wound to foot; patient 4, fall. All resulted in a visit to a hospital emergency department without inpatient admission. None related to study participation.
Frequency: 1 affected / 110 at risk

Adverse event: Fibromyalgia pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Exacerbation of existing fibromyalgia pain resulting in a visit to a hospital emergency department. No inpatient admission. Unrelated to study participation.
Frequency: 1 affected / 110 at risk

Adverse event: Emergency department, unspecified
Serious: no
Organ System: General disorders
Notes: Unspecified events resulting in a visit to a hospital emergency department without inpatient admission. Unrelated to study participation.
Frequency: 23 affected / 110 at risk