Study: NCT01918800

Adverse event: MS related
Serious: yes
Organ System: Nervous system disorders
Notes: unrelated to research
Frequency: 1 affected / 109 at risk

Adverse event: Surgery
Serious: yes
Organ System: Surgical and medical procedures
Notes: unrelated to research
Frequency: 1 affected / 109 at risk

Adverse event: Fracture from a fall
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: unrelated to research
Frequency: 1 affected / 109 at risk

Adverse event: Neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: unrelated to research
Frequency: 1 affected / 109 at risk

Adverse event: Constipation requiring hospitalization
Serious: yes
Organ System: Gastrointestinal disorders
Notes: unrelated to research
Frequency: 1 affected / 109 at risk

Adverse event: Bee sting reaction
Serious: yes
Organ System: Immune system disorders
Notes: unrelated to research
Frequency: 1 affected / 109 at risk

Adverse event: Social circumstances
Serious: yes
Organ System: Social circumstances
Notes: unrelated to research
Frequency: 1 affected / 109 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Notes: unrelated to research
Frequency: 1 affected / 109 at risk

Adverse event: MS exacerbation
Serious: yes
Organ System: Nervous system disorders
Notes: unrelated to research
Frequency: 1 affected / 109 at risk

Adverse event: Chest pain. Undetermined orgin.
Serious: no
Organ System: Cardiac disorders
Notes: unrelated
Frequency: 1 affected / 109 at risk

Adverse event: nausea-diarrhea
Serious: no
Organ System: Gastrointestinal disorders
Notes: unrelated
Frequency: 1 affected / 109 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: unrelated
Frequency: 1 affected / 109 at risk

Adverse event: Root canal
Serious: no
Organ System: General disorders
Notes: unrelated
Frequency: 1 affected / 109 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Notes: unrelated
Frequency: 1 affected / 109 at risk

Adverse event: worsening headaches
Serious: no
Organ System: General disorders
Notes: unrelated
Frequency: 1 affected / 109 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Notes: unrelated
Frequency: 1 affected / 109 at risk

Adverse event: Increased pain left side of body
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: unrelated
Frequency: 1 affected / 109 at risk

Adverse event: fall due to lightheadness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: unrelated
Frequency: 1 affected / 109 at risk

Adverse event: increased spasticity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: unrelated
Frequency: 1 affected / 109 at risk

Adverse event: left arm pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: unrelated
Frequency: 1 affected / 109 at risk

Adverse event: right thigh soreness on ambulation
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: unrelated
Frequency: 1 affected / 109 at risk

Adverse event: weakenss in right thigh
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: unrelated
Frequency: 1 affected / 109 at risk

Adverse event: strained groin muscle
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: unrelated
Frequency: 1 affected / 109 at risk

Adverse event: increased shakiness in right arm
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: unrelated
Frequency: 1 affected / 109 at risk

Adverse event: Right arm tendonitis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: unrelated
Frequency: 1 affected / 109 at risk

Adverse event: left shoulder/arm pain into mid back with back spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: unrelated
Frequency: 1 affected / 109 at risk

Adverse event: Fall
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: unrelated
Frequency: 1 affected / 109 at risk

Adverse event: Increased pain following car accident
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: unrelated
Frequency: 1 affected / 109 at risk

Adverse event: Musculoskeletal
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: unrelated
Frequency: 1 affected / 109 at risk

Adverse event: MS related
Serious: no
Organ System: Nervous system disorders
Notes: unrelated
Frequency: 1 affected / 109 at risk

Adverse event: Migraine
Serious: no
Organ System: Nervous system disorders
Notes: unrelated
Frequency: 1 affected / 109 at risk

Adverse event: Cluster headache
Serious: no
Organ System: Nervous system disorders
Notes: unrelated
Frequency: 1 affected / 109 at risk

Adverse event: worsening insomnia
Serious: no
Organ System: Nervous system disorders
Notes: unrelated
Frequency: 1 affected / 109 at risk

Adverse event: Insomnia, dizziness, fatigue
Serious: no
Organ System: Nervous system disorders
Notes: unrelated
Frequency: 1 affected / 109 at risk

Adverse event: tremors and increased fatigue
Serious: no
Organ System: Nervous system disorders
Notes: unrelated
Frequency: 1 affected / 109 at risk

Adverse event: changes in peripheral vision
Serious: no
Organ System: Nervous system disorders
Notes: unrelated
Frequency: 1 affected / 109 at risk

Adverse event: Left heel drop
Serious: no
Organ System: Nervous system disorders
Notes: unrelated
Frequency: 1 affected / 109 at risk

Adverse event: Mental disorientation
Serious: no
Organ System: Nervous system disorders
Notes: unrelated
Frequency: 1 affected / 109 at risk

Adverse event: epidural steroid injections for pain
Serious: no
Organ System: Nervous system disorders
Notes: unrelated
Frequency: 1 affected / 109 at risk

Adverse event: muscle spasms, neck
Serious: no
Organ System: Nervous system disorders
Notes: unrelated
Frequency: 1 affected / 109 at risk

Adverse event: Diagnosis of external snapping hip syndrome
Serious: no
Organ System: Nervous system disorders
Notes: unrelated
Frequency: 1 affected / 109 at risk

Adverse event: Loss of feeling in vulvar glands
Serious: no
Organ System: Nervous system disorders
Notes: unrelated
Frequency: 1 affected / 109 at risk

Adverse event: Myalgia
Serious: no
Organ System: Nervous system disorders
Notes: unrelated
Frequency: 1 affected / 109 at risk

Adverse event: excessive fatigue: physical and cognitive change
Serious: no
Organ System: Nervous system disorders
Notes: unrelated
Frequency: 1 affected / 109 at risk

Adverse event: MS related
Serious: no
Organ System: Nervous system disorders
Notes: unrelated
Frequency: 1 affected / 109 at risk

Adverse event: Angioedema for side effects of bladder medication
Serious: no
Organ System: Renal and urinary disorders
Notes: unrelated
Frequency: 1 affected / 109 at risk

Adverse event: hernia; seen by primary care MD
Serious: no
Organ System: Renal and urinary disorders
Notes: unrelated
Frequency: 1 affected / 109 at risk

Adverse event: Greater difficulty breathing. Cardiac tests negative. Referred to a pulmonologist.
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: unrelated
Frequency: 1 affected / 109 at risk

Adverse event: persistant cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: unrelated
Frequency: 1 affected / 109 at risk

Adverse event: Upper respiratory/cold
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: unrelated
Frequency: 1 affected / 109 at risk

Adverse event: Piece of metal in foot
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: unrelated
Frequency: 1 affected / 109 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: unrelated
Frequency: 1 affected / 109 at risk

Adverse event: Pruritis skin condition
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: unrelated
Frequency: 1 affected / 109 at risk

Adverse event: Skin problems
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: unrelated
Frequency: 1 affected / 109 at risk

Adverse event: Emotional
Serious: no
Organ System: Social circumstances
Notes: unrelated
Frequency: 1 affected / 109 at risk

Adverse event: Fracture from a fall
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: unrelated to research
Frequency: 1 affected / 109 at risk

Adverse event: Hospitalization for mental health
Serious: yes
Organ System: Social circumstances
Notes: unrelated to research
Frequency: 1 affected / 109 at risk

Adverse event: Neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: unrelated to research
Frequency: 1 affected / 109 at risk

Adverse event: Defibrulator change resulting in hospitalization
Serious: yes
Organ System: Cardiac disorders
Notes: unrelated to research
Frequency: 1 affected / 109 at risk

Adverse event: Hernia
Serious: yes
Organ System: Renal and urinary disorders
Notes: unrelated to research
Frequency: 1 affected / 109 at risk

Adverse event: Syncopal event
Serious: yes
Organ System: Nervous system disorders
Notes: unrelated to research
Frequency: 1 affected / 109 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: unrelated to research
Frequency: 1 affected / 109 at risk

Adverse event: Band sensation
Serious: yes
Organ System: Nervous system disorders
Notes: unrelated to research
Frequency: 1 affected / 109 at risk

Adverse event: Chest pain
Serious: yes
Organ System: Cardiac disorders
Notes: unrelated to research
Frequency: 1 affected / 109 at risk

Adverse event: Shortness of breath and chest pains.
Serious: no
Organ System: Cardiac disorders
Notes: unrelated
Frequency: 1 affected / 109 at risk

Adverse event: Gastrointestinal pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: unrelated
Frequency: 1 affected / 109 at risk

Adverse event: abdominal pain due to gastroparesis
Serious: no
Organ System: Gastrointestinal disorders
Notes: unrelated
Frequency: 1 affected / 109 at risk

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Notes: unrelated
Frequency: 1 affected / 109 at risk

Adverse event: Hot flush
Serious: no
Organ System: General disorders
Notes: unrelated
Frequency: 1 affected / 109 at risk

Adverse event: hot flashes, fatigue and tremors
Serious: no
Organ System: General disorders
Notes: unrelated
Frequency: 1 affected / 109 at risk

Adverse event: Vertigo
Serious: no
Organ System: General disorders
Notes: unrelated
Frequency: 1 affected / 109 at risk

Adverse event: Dizziness/balance
Serious: no
Organ System: General disorders
Notes: unrelated
Frequency: 1 affected / 109 at risk

Adverse event: sedation/fainting from side effects of bladder medication
Serious: no
Organ System: General disorders
Notes: unrelated
Frequency: 1 affected / 109 at risk

Adverse event: headache/migraine
Serious: no
Organ System: General disorders
Notes: unrelated
Frequency: 1 affected / 109 at risk

Adverse event: Increase in headaches, vertigo, weakness and fatigue
Serious: no
Organ System: General disorders
Notes: unrelated
Frequency: 1 affected / 109 at risk

Adverse event: Headaches
Serious: no
Organ System: General disorders
Notes: unrelated
Frequency: 1 affected / 109 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Notes: unrelated
Frequency: 1 affected / 109 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Notes: unrelated
Frequency: 1 affected / 109 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Notes: unrelated
Frequency: 1 affected / 109 at risk

Adverse event: Fall
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: unrelated
Frequency: 1 affected / 109 at risk

Adverse event: right hand pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: unrelated
Frequency: 1 affected / 109 at risk

Adverse event: Broken tooth
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: unrelated
Frequency: 1 affected / 109 at risk

Adverse event: Worsening focus and attention problems
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: unrelated
Frequency: 1 affected / 109 at risk

Adverse event: pain/stiffness/locking in left hip (from torn ligament)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: unrelated
Frequency: 1 affected / 109 at risk

Adverse event: left knee pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: unrelated
Frequency: 1 affected / 109 at risk

Adverse event: right leg weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: unrelated
Frequency: 1 affected / 109 at risk

Adverse event: swollen foot
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: unrelated
Frequency: 1 affected / 109 at risk

Adverse event: left arm pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: unrelated
Frequency: 1 affected / 109 at risk

Adverse event: Worsening of left knee. Hyperextension and weakness.
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: unrelated
Frequency: 1 affected / 109 at risk

Adverse event: right hip increased ache, stiffness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: unrelated
Frequency: 1 affected / 109 at risk

Adverse event: Fever, body aches
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: unrelated
Frequency: 1 affected / 109 at risk

Adverse event: Increase in pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: unrelated
Frequency: 1 affected / 109 at risk

Adverse event: heel spur
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: unrelated
Frequency: 1 affected / 109 at risk

Adverse event: Musculoskeletal
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: unrelated
Frequency: 1 affected / 109 at risk

Adverse event: MS flareup; 5 days of sterioids (outpatient visits)
Serious: no
Organ System: Nervous system disorders
Notes: unrelated
Frequency: 1 affected / 109 at risk

Adverse event: chest pain related to MS flare-up
Serious: no
Organ System: Nervous system disorders
Notes: unrelated
Frequency: 1 affected / 109 at risk

Adverse event: Fatigue
Serious: no
Organ System: Nervous system disorders
Notes: unrelated
Frequency: 1 affected / 109 at risk

Adverse event: MS exacerbation: leg weakness
Serious: no
Organ System: Nervous system disorders
Notes: unrelated
Frequency: 1 affected / 109 at risk

Adverse event: MS exacerbation: suspected optic neurtits (blurred vision)
Serious: no
Organ System: Nervous system disorders
Notes: unrelated
Frequency: 1 affected / 109 at risk

Adverse event: MS exacerbation:spine curvature, stiffness, spasticity
Serious: no
Organ System: Nervous system disorders
Notes: unrelated
Frequency: 1 affected / 109 at risk

Adverse event: facial numbness
Serious: no
Organ System: Nervous system disorders
Notes: unrelated
Frequency: 1 affected / 109 at risk

Adverse event: Increased leg weakness & declining mobility
Serious: no
Organ System: Nervous system disorders
Notes: unrelated
Frequency: 1 affected / 109 at risk

Adverse event: increased facial pain right side below right eye
Serious: no
Organ System: Nervous system disorders
Notes: unrelated
Frequency: 1 affected / 109 at risk

Adverse event: increased fatigue, spasticity, and tingling.
Serious: no
Organ System: Nervous system disorders
Notes: unrelated
Frequency: 1 affected / 109 at risk

Adverse event: Increased fatigue
Serious: no
Organ System: Nervous system disorders
Notes: unrelated
Frequency: 1 affected / 109 at risk

Adverse event: MS related
Serious: no
Organ System: Nervous system disorders
Notes: unrelated
Frequency: 1 affected / 109 at risk

Adverse event: MS related
Serious: no
Organ System: Nervous system disorders
Notes: unrelated
Frequency: 1 affected / 109 at risk

Adverse event: MS related
Serious: no
Organ System: Nervous system disorders
Notes: unrelated
Frequency: 1 affected / 1 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Renal and urinary disorders
Notes: unrelated
Frequency: 1 affected / 109 at risk

Adverse event: Recurrent right inguinal hernia
Serious: no
Organ System: Renal and urinary disorders
Notes: unrelated
Frequency: 1 affected / 109 at risk

Adverse event: bladder issues exacerbated by levoquin antibiotic for bronchitis
Serious: no
Organ System: Renal and urinary disorders
Notes: unrelated
Frequency: 1 affected / 109 at risk

Adverse event: Brusing of uterus, and fallopian tubes
Serious: no
Organ System: Reproductive system and breast disorders
Notes: unrelated
Frequency: 1 affected / 109 at risk

Adverse event: Hemorragic ovarian cysts
Serious: no
Organ System: Reproductive system and breast disorders
Notes: unrelated
Frequency: 1 affected / 109 at risk

Adverse event: Vulvovaginal dryness
Serious: no
Organ System: Reproductive system and breast disorders
Notes: unrelated
Frequency: 1 affected / 109 at risk

Adverse event: Breathing/sinus difficutlies from deviated septum surgery
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: unrelated
Frequency: 1 affected / 109 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: unrelated
Frequency: 1 affected / 109 at risk

Adverse event: sinitus
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: unrelated
Frequency: 1 affected / 109 at risk

Adverse event: Upper respiratory/cold
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: unrelated
Frequency: 1 affected / 109 at risk

Adverse event: prutiis skin condition
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: unrelated
Frequency: 1 affected / 109 at risk

Adverse event: skin lesions possible due to injection reaction
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: unrelated
Frequency: 1 affected / 109 at risk

Adverse event: Skin problems
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: unrelated
Frequency: 1 affected / 109 at risk

Adverse event: increase in anxiety
Serious: no
Organ System: Social circumstances
Notes: unrelated
Frequency: 1 affected / 109 at risk

Adverse event: Emotional
Serious: no
Organ System: Social circumstances
Notes: unrelated
Frequency: 1 affected / 109 at risk