Study: NCT01198977

Adverse event: car accident not related to study
Serious: yes
Organ System: Cardiac disorders
Notes: ER visit for syncopal episode after accident: hypotensive and bradycardic.
Frequency: 1 affected / 31 at risk

Adverse event: MS exacerbation
Serious: yes
Organ System: Nervous system disorders
Notes: Treated with IV steroids inpatient.
Frequency: 1 affected / 31 at risk

Adverse event: Fall
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Fall from ladder
Frequency: 1 affected / 31 at risk

Adverse event: Suicidal ideation
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 31 at risk

Adverse event: Pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 31 at risk

Adverse event: Cut Thumb
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Cut Thumb while sawing tree
Frequency: 1 affected / 31 at risk

Adverse event: Fall
Serious: no
Organ System: Nervous system disorders
Notes: Balance problems due to multiple sclerosis injuries from fall: twisted ankle, skinned hand, sore back, strained shoulder,
Frequency: 6 affected / 31 at risk

Adverse event: Increased MS Symptoms
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 31 at risk

Adverse event: Ulcer
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 31 at risk

Adverse event: Optic neuritis
Serious: no
Organ System: Eye disorders
Notes: from MS exacerbation
Frequency: 1 affected / 31 at risk

Adverse event: MS exacerbation
Serious: no
Organ System: Nervous system disorders
Notes: outpatient
Frequency: 2 affected / 31 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 31 at risk

Adverse event: muscle soreness from exercise
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 31 at risk

Adverse event: Hypoaesthesia
Serious: no
Organ System: Nervous system disorders
Notes: MS symptom increase
Frequency: 2 affected / 31 at risk

Adverse event: Mobility
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 31 at risk

Adverse event: Fatigue
Serious: no
Organ System: Nervous system disorders
Notes: due to MS
Frequency: 2 affected / 31 at risk

Adverse event: MS exacerbation
Serious: yes
Organ System: Nervous system disorders
Notes: Treated with IV steroids inpatient.
Frequency: 2 affected / 33 at risk

Adverse event: Overnight hospital stay - 24 hour observation of first dose of Fingolimod
Serious: yes
Organ System: Nervous system disorders
Notes: MS disease modifying therapy. Requires overnight observation to new users.
Frequency: 1 affected / 33 at risk

Adverse event: Routine Overnight Inpatient Hospital Stay for MS Evaluation
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 33 at risk

Adverse event: Suicidal ideation
Serious: no
Organ System: Psychiatric disorders
Frequency: 5 affected / 33 at risk

Adverse event: Pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 33 at risk

Adverse event: Fall
Serious: no
Organ System: Nervous system disorders
Notes: Balance problems due to multiple sclerosis injuries from fall: twisted ankle, skinned hand, sore back, strained shoulder,
Frequency: 3 affected / 33 at risk

Adverse event: MS exacerbation
Serious: no
Organ System: Nervous system disorders
Notes: outpatient
Frequency: 2 affected / 33 at risk

Adverse event: Pleurisy
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: from having bronchitis
Frequency: 1 affected / 33 at risk

Adverse event: Hypoaesthesia
Serious: no
Organ System: Nervous system disorders
Notes: MS symptom increase
Frequency: 1 affected / 33 at risk

Adverse event: Dysarthria
Serious: no
Organ System: Nervous system disorders
Notes: MS symptom
Frequency: 1 affected / 33 at risk

Adverse event: Mobility
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 33 at risk

Adverse event: Fatigue
Serious: no
Organ System: Nervous system disorders
Notes: due to MS
Frequency: 3 affected / 33 at risk