Study: NCT01911676

Adverse event: Increased Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 34 at risk

Adverse event: High Blood Pressure
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 34 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 3 affected / 34 at risk

Adverse event: GI Discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 34 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 34 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 34 at risk

Adverse event: Elevated AST/ALT
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 34 at risk

Adverse event: Whiplash
Serious: no
Organ System: General disorders
Frequency: 1 affected / 34 at risk

Adverse event: Trigeminal neuralgia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 34 at risk

Adverse event: Vertigo
Serious: no
Organ System: General disorders
Frequency: 1 affected / 34 at risk

Adverse event: Orthostatic hypotension
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 34 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: General disorders
Frequency: 3 affected / 34 at risk

Adverse event: Stomach Cramps/Discomfort
Serious: no
Organ System: General disorders
Frequency: 1 affected / 34 at risk

Adverse event: Limb injury
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 34 at risk

Adverse event: Increase in Pain as a Result of Spinal Surgery Prior to Study
Serious: no
Organ System: General disorders
Frequency: 1 affected / 34 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: General disorders
Frequency: 1 affected / 34 at risk

Adverse event: Pharyngeal Pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 34 at risk

Adverse event: Increased appetite
Serious: no
Organ System: General disorders
Frequency: 1 affected / 34 at risk

Adverse event: Productive Cough / Chest Congestion
Serious: no
Organ System: General disorders
Frequency: 1 affected / 34 at risk

Adverse event: Increase in Fibromyalgia Pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 34 at risk

Adverse event: Depressed mood
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 34 at risk

Adverse event: Gum Soreness (at site of tooth extraction)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 34 at risk

Adverse event: Sore Shoulder
Serious: no
Organ System: General disorders
Frequency: 1 affected / 34 at risk

Adverse event: Hospitalization from Intent to Overdose on Meds / Suicidal Ideation
Serious: yes
Organ System: Social circumstances
Frequency: 1 affected / 33 at risk

Adverse event: Hospitalization Due to Stroke
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 33 at risk

Adverse event: Increased Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 33 at risk

Adverse event: Vision blurred
Serious: no
Organ System: General disorders
Frequency: 2 affected / 33 at risk

Adverse event: Sleep disorder
Serious: no
Organ System: General disorders
Frequency: 2 affected / 33 at risk

Adverse event: Hand Tremor
Serious: no
Organ System: General disorders
Frequency: 1 affected / 33 at risk

Adverse event: Foul Smelling Odor in Urine
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 33 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 3 affected / 33 at risk

Adverse event: GI Discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 33 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 33 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 33 at risk

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

Adverse event: Cough
Serious: no
Organ System: General disorders
Frequency: 1 affected / 33 at risk

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

Adverse event: Hot flush
Serious: no
Organ System: General disorders
Frequency: 1 affected / 33 at risk

Adverse event: Reduced Appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 33 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: General disorders
Frequency: 1 affected / 33 at risk

Adverse event: Tooth Pulled
Serious: no
Organ System: General disorders
Frequency: 1 affected / 33 at risk

Adverse event: Stomach Cramps/Discomfort
Serious: no
Organ System: General disorders
Frequency: 2 affected / 33 at risk

Adverse event: Increased Sleep
Serious: no
Organ System: General disorders
Frequency: 1 affected / 33 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 33 at risk

Adverse event: Dehydration
Serious: no
Organ System: General disorders
Frequency: 1 affected / 33 at risk

Adverse event: Reduced Sleep
Serious: no
Organ System: General disorders
Frequency: 1 affected / 33 at risk

Adverse event: Productive Cough / Chest Congestion
Serious: no
Organ System: General disorders
Frequency: 1 affected / 33 at risk

Adverse event: Paronychia (Right Middle Finger)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 33 at risk

Adverse event: Contact Dermatitis on Forehead
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 33 at risk

Adverse event: Musculoskeletal stiffness
Serious: no
Organ System: General disorders
Frequency: 2 affected / 33 at risk

Adverse event: Light Sensitivity
Serious: no
Organ System: General disorders
Frequency: 1 affected / 33 at risk

Adverse event: Pneumonia in Right Lung
Serious: no
Organ System: General disorders
Frequency: 1 affected / 33 at risk

Adverse event: Increased Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 63 at risk

Adverse event: Vision blurred
Serious: no
Organ System: General disorders
Frequency: 2 affected / 63 at risk

Adverse event: Sleep disorder
Serious: no
Organ System: General disorders
Frequency: 4 affected / 63 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 63 at risk

Adverse event: High Blood Pressure
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 63 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 63 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 2 affected / 63 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 63 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 63 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 63 at risk

Adverse event: Bruised Forearms
Serious: no
Organ System: General disorders
Frequency: 1 affected / 63 at risk

Adverse event: Lower Back Strain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 63 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: General disorders
Frequency: 1 affected / 63 at risk

Adverse event: Stomach Cramps/Discomfort
Serious: no
Organ System: General disorders
Frequency: 1 affected / 63 at risk

Adverse event: Increased Sleep
Serious: no
Organ System: General disorders
Frequency: 3 affected / 63 at risk

Adverse event: Nausea / Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 63 at risk

Adverse event: Vasovagal Response
Serious: no
Organ System: General disorders
Frequency: 1 affected / 63 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 63 at risk

Adverse event: Suicidal Ideation Due to Psychosocial Stressors
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 63 at risk

Adverse event: Reduced Sleep
Serious: no
Organ System: General disorders
Frequency: 1 affected / 63 at risk

Adverse event: Increased appetite
Serious: no
Organ System: General disorders
Frequency: 3 affected / 63 at risk

Adverse event: Productive Cough / Chest Congestion
Serious: no
Organ System: General disorders
Frequency: 1 affected / 63 at risk

Adverse event: Eye Sensitivity
Serious: no
Organ System: General disorders
Frequency: 1 affected / 63 at risk

Adverse event: Intermittent Blurred Vision
Serious: no
Organ System: General disorders
Frequency: 1 affected / 63 at risk

Adverse event: Depressed mood
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 63 at risk

Adverse event: Increased Discomfort Associated with Pre-Existing Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 63 at risk

Adverse event: Acute Ear Pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 63 at risk

Adverse event: Hip Pain (associated with pre-existing bone spur)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 63 at risk

Adverse event: Sinus congestion
Serious: no
Organ System: General disorders
Frequency: 1 affected / 63 at risk

Adverse event: Sleep disorder
Serious: no
Organ System: General disorders
Frequency: 1 affected / 59 at risk

Adverse event: High Blood Pressure
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 59 at risk

Adverse event: Ligament sprain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 59 at risk

Adverse event: Bell's palsy
Serious: no
Organ System: General disorders
Frequency: 1 affected / 59 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 2 affected / 59 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 2 affected / 59 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: General disorders
Frequency: 5 affected / 59 at risk

Adverse event: Tooth Pulled
Serious: no
Organ System: General disorders
Frequency: 1 affected / 59 at risk

Adverse event: Limb injury
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 59 at risk

Adverse event: Nausea / Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 59 at risk

Adverse event: Laryngitis
Serious: no
Organ System: General disorders
Frequency: 1 affected / 59 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 59 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 59 at risk

Adverse event: Increase in Pre-Existing Headache
Serious: no
Organ System: General disorders
Frequency: 1 affected / 59 at risk

Adverse event: Increased Urination
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 59 at risk

Adverse event: Decreased Sleep (Associated with Pre-Existing Sleep Apnea)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 59 at risk

Adverse event: Intermittent Dental Pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 59 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 59 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: General disorders
Frequency: 1 affected / 59 at risk

Adverse event: Contact Dermatitis on Forehead
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 59 at risk

Adverse event: Wrist Drop / Radial Nerve Palsy
Serious: no
Organ System: General disorders
Frequency: 1 affected / 59 at risk

Adverse event: Front Tooth Pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 59 at risk