Study: NCT03468868

Adverse event: Coronavirus infections
Serious: yes
Organ System: Infections and infestations
Notes: This SAE was determined to be not related to the study intervention.
Frequency: 2 affected / 198 at risk

Adverse event: Elective hip arthroplasty
Serious: yes
Organ System: Surgical and medical procedures
Notes: This SAE was determined to be not related to the study intervention.
Frequency: 1 affected / 198 at risk

Adverse event: Fall resulting in fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: This SAE was determined to be not related to the study intervention.
Frequency: 2 affected / 198 at risk

Adverse event: Increase in multiple sclerosis (MS) symptoms
Serious: yes
Organ System: Nervous system disorders
Notes: Participant missed an infusion of their disease-modifying therapy (DMT) which led to a severe increase in MS symptoms and hospitalization. This SAE was determined to be not related to the study intervention.
Frequency: 1 affected / 198 at risk

Adverse event: Septic shock of unknown etiology
Serious: yes
Organ System: Infections and infestations
Notes: This SAE was determined to be not related to the study intervention.
Frequency: 1 affected / 198 at risk

Adverse event: Viral infection
Serious: yes
Organ System: Infections and infestations
Notes: This SAE was determined to be not related to the study intervention.
Frequency: 1 affected / 198 at risk

Adverse event: Coronavirus infection
Serious: no
Organ System: Infections and infestations
Notes: All were determined to be not related to the study intervention.
Frequency: 8 affected / 198 at risk

Adverse event: Dental conditions
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Reported conditions included pain (2) and a fractured tooth (1). All were determined to be not related to the study intervention.
Frequency: 2 affected / 198 at risk

Adverse event: Fall with injury
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Injuries included minor skin abrasions, bruising, soreness, pain, sprain, fracture (3), and concussion (1). Of the 59 fall with injury events, 2 were determined to be possibly related, and 3 were determined to be related to the study intervention.
Frequency: 25 affected / 198 at risk

Adverse event: Fall without injury
Serious: no
Organ System: General disorders
Notes: Of the 44 fall without injury events, 3 were determined to be possibly related, and 8 were determined to be related to the study intervention.
Frequency: 19 affected / 198 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Gastrointestinal disorders
Notes: All were determined to be not related to the study intervention.
Frequency: 4 affected / 198 at risk

Adverse event: General illness
Serious: no
Organ System: General disorders
Notes: General illness included general, undiagnosed reports of feeling "sick". All were determined to be not related to the study intervention.
Frequency: 1 affected / 198 at risk

Adverse event: Temperature intolerance
Serious: no
Organ System: Nervous system disorders
Notes: Of the 3 heat intolerance events, 1 was determined to be possibly related, and 1 was determined to be related to the study intervention.
Frequency: 1 affected / 198 at risk

Adverse event: Influenza Infection
Serious: no
Organ System: Infections and infestations
Notes: All were determined to be not related to the study intervention.
Frequency: 1 affected / 198 at risk

Adverse event: Medication side effects
Serious: no
Organ System: Nervous system disorders
Notes: All were determined to be not related to the study intervention.
Frequency: 1 affected / 198 at risk

Adverse event: Motor Vehicle Accident (MVA) with Sequelae
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: All were determined to be not related to the study intervention.
Frequency: 2 affected / 198 at risk

Adverse event: Multiple Sclerosis (MS) Flare
Serious: no
Organ System: Nervous system disorders
Notes: Of the 8 MS flare events, 1 was determined to be possibly related to the study intervention.
Frequency: 2 affected / 198 at risk

Adverse event: Neurological Symptoms
Serious: no
Organ System: Nervous system disorders
Notes: Events included numbness (1), neuralgia (1), blurred vision (1), optic neuritis (1), increased spasticity (2), and worsening balance (2). Of the 8 neurological events, 5 were determined to be possibly related.
Frequency: 6 affected / 198 at risk

Adverse event: Other Musculoskeletal Conditions
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Events included swelling, tendonitis, sprain, and spinal stenosis. Of the 8 events, 3 were determined to be possibly related, and 1 was determined to be related to the study intervention.
Frequency: 1 affected / 198 at risk

Adverse event: Pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Pain was reported at the ankle (1), back (14), chest (3), elbow (1), foot (2), hip (3), knee (10), leg (2), neck (2), pelvis (1), shoulder (5), and thigh (1). Of the 48 events, 18 were possibly related, and 5 were related to the study intervention.
Frequency: 19 affected / 198 at risk

Adverse event: Symptoms post-COVID vaccine
Serious: no
Organ System: Immune system disorders
Notes: All were determined to be not related to the study intervention.
Frequency: 3 affected / 198 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Notes: All were determined to be not related to the study intervention.
Frequency: 2 affected / 198 at risk

Adverse event: Vertigo
Serious: no
Organ System: Nervous system disorders
Notes: All were determined to be not related to the study intervention.
Frequency: 2 affected / 198 at risk

Adverse event: Asthenia
Serious: no
Organ System: Nervous system disorders
Notes: Of the 6 reports of weakness, 5 were determined to be possibly related to the study intervention.
Frequency: 1 affected / 198 at risk

Adverse event: Coronavirus infections
Serious: yes
Organ System: Infections and infestations
Notes: This SAE was determined to be not related to the study intervention.
Frequency: 1 affected / 181 at risk

Adverse event: Intervertebral disc protrusion
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: This SAE was determined to be not related to the study intervention.
Frequency: 1 affected / 181 at risk

Adverse event: Coronavirus infection
Serious: no
Organ System: Infections and infestations
Notes: All were determined to be not related to the study intervention.
Frequency: 7 affected / 181 at risk

Adverse event: Dental conditions
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Reported conditions included pain (2) and a fractured tooth (1). All were determined to be not related to the study intervention.
Frequency: 1 affected / 181 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Notes: All were determined to be not related to the study intervention.
Frequency: 2 affected / 181 at risk

Adverse event: Fall with injury
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Injuries included minor skin abrasions, bruising, soreness, pain, sprain, fracture (3), and concussion (1). Of the 59 fall with injury events, 2 were determined to be possibly related, and 3 were determined to be related to the study intervention.
Frequency: 26 affected / 181 at risk

Adverse event: Fall without injury
Serious: no
Organ System: General disorders
Notes: Of the 44 fall without injury events, 3 were determined to be possibly related, and 8 were determined to be related to the study intervention.
Frequency: 16 affected / 181 at risk

Adverse event: Fatigue
Serious: no
Organ System: Nervous system disorders
Notes: Of the 4 fatigue events, 1 was determined to be possibly related, and 1 was determined to be related to the study intervention.
Frequency: 4 affected / 181 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Gastrointestinal disorders
Notes: All were determined to be not related to the study intervention.
Frequency: 2 affected / 181 at risk

Adverse event: General illness
Serious: no
Organ System: General disorders
Notes: General illness included general, undiagnosed reports of feeling "sick". All were determined to be not related to the study intervention.
Frequency: 3 affected / 181 at risk

Adverse event: Temperature intolerance
Serious: no
Organ System: Nervous system disorders
Notes: Of the 3 heat intolerance events, 1 was determined to be possibly related, and 1 was determined to be related to the study intervention.
Frequency: 2 affected / 181 at risk

Adverse event: Influenza Infection
Serious: no
Organ System: Infections and infestations
Notes: All were determined to be not related to the study intervention.
Frequency: 2 affected / 181 at risk

Adverse event: Medication side effects
Serious: no
Organ System: Nervous system disorders
Notes: All were determined to be not related to the study intervention.
Frequency: 3 affected / 181 at risk

Adverse event: Migraine
Serious: no
Organ System: Nervous system disorders
Notes: Of the 2 migraine events, 1 was determined to be possibly related to the study intervention.
Frequency: 2 affected / 181 at risk

Adverse event: Motor Vehicle Accident (MVA) with Sequelae
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: All were determined to be not related to the study intervention.
Frequency: 3 affected / 181 at risk

Adverse event: Multiple Sclerosis (MS) Flare
Serious: no
Organ System: Nervous system disorders
Notes: Of the 8 MS flare events, 1 was determined to be possibly related to the study intervention.
Frequency: 5 affected / 181 at risk

Adverse event: Multiple Sclerosis (MS) Relapse
Serious: no
Organ System: Nervous system disorders
Notes: Events were categorized as MS relapses only if diagnosed by a neurologist as such. All were determined to be not related to the study intervention.
Frequency: 2 affected / 181 at risk

Adverse event: Neurological Symptoms
Serious: no
Organ System: Nervous system disorders
Notes: Events included numbness (1), neuralgia (1), blurred vision (1), optic neuritis (1), increased spasticity (2), and worsening balance (2). Of the 8 neurological events, 5 were determined to be possibly related.
Frequency: 2 affected / 181 at risk

Adverse event: Other Musculoskeletal Conditions
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Events included swelling, tendonitis, sprain, and spinal stenosis. Of the 8 events, 3 were determined to be possibly related, and 1 was determined to be related to the study intervention.
Frequency: 6 affected / 181 at risk

Adverse event: Pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Pain was reported at the ankle (1), back (14), chest (3), elbow (1), foot (2), hip (3), knee (10), leg (2), neck (2), pelvis (1), shoulder (5), and thigh (1). Of the 48 events, 18 were possibly related, and 5 were related to the study intervention.
Frequency: 24 affected / 181 at risk

Adverse event: Symptoms post-COVID vaccine
Serious: no
Organ System: Immune system disorders
Notes: All were determined to be not related to the study intervention.
Frequency: 4 affected / 181 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: All were determined to be not related to the study intervention.
Frequency: 9 affected / 181 at risk

Adverse event: Vertigo
Serious: no
Organ System: Nervous system disorders
Notes: All were determined to be not related to the study intervention.
Frequency: 1 affected / 181 at risk

Adverse event: Asthenia
Serious: no
Organ System: Nervous system disorders
Notes: Of the 6 reports of weakness, 5 were determined to be possibly related to the study intervention.
Frequency: 5 affected / 181 at risk