Study: NCT01016678

Adverse event: Prolonged Migraine
Serious: yes
Organ System: Nervous system disorders
Notes: Patient was treated in the hospital for a prolonged migraine but it was not related to study drug. Study drug was taken 10 days prior to event onset.
Frequency: 1 affected / 20 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Notes: The percentage of occurrence was 4.3%
Frequency: 1 affected / 20 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: Cough
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 20 at risk

Adverse event: Neck Spasm/Tension
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: The percentage of occurrence was 6.4%
Frequency: 1 affected / 17 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Notes: The percentage of occurrence was 4.3%
Frequency: 2 affected / 17 at risk

Adverse event: Throat tightness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: The percentage of occurrence was 5%
Frequency: 1 affected / 17 at risk

Adverse event: Stiff Jaw
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Tightness or Stiff feeling in jaw
Frequency: 2 affected / 17 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 17 at risk

Adverse event: Tongue Swelling
Serious: no
Organ System: General disorders
Frequency: 1 affected / 17 at risk

Adverse event: Burning Sensation Face
Serious: no
Organ System: General disorders
Frequency: 1 affected / 17 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 17 at risk

Adverse event: Bruised Coccyx
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 17 at risk

Adverse event: Broken Right Arm
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 17 at risk

Adverse event: Weird Feeling, Out of Body Sensation
Serious: no
Organ System: General disorders
Frequency: 1 affected / 17 at risk

Adverse event: Neck Spasm/Tension
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: The percentage of occurrence was 6.4%
Frequency: 3 affected / 19 at risk

Adverse event: Hypoaesthesia
Serious: no
Organ System: Nervous system disorders
Notes: Numbness in Extremities
Frequency: 2 affected / 19 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 19 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 19 at risk

Adverse event: Throat tightness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: The percentage of occurrence was 5%
Frequency: 1 affected / 19 at risk

Adverse event: Burning Sensation Face
Serious: no
Organ System: General disorders
Frequency: 1 affected / 19 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 19 at risk

Adverse event: Dermatitis contact
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 19 at risk

Adverse event: Herpes Simplex Right Eye
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 19 at risk

Adverse event: Abcess Right Leg
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 19 at risk

Adverse event: Cough
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 19 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 19 at risk

Adverse event: Neck Spasm/Tension
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: The percentage of occurrence was 6.4%
Frequency: 2 affected / 19 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Notes: The percentage of occurrence was 4.3%
Frequency: 1 affected / 19 at risk

Adverse event: Throat tightness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: The percentage of occurrence was 5%
Frequency: 3 affected / 19 at risk

Adverse event: Stiff Jaw
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Tightness or Stiff feeling in jaw
Frequency: 1 affected / 19 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 19 at risk

Adverse event: Tongue Swelling
Serious: no
Organ System: General disorders
Frequency: 1 affected / 19 at risk

Adverse event: Hypoaesthesia
Serious: no
Organ System: Nervous system disorders
Notes: Numbness in Extremities
Frequency: 1 affected / 19 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 19 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 19 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 19 at risk