Study: NCT03139916

Adverse event: Cognitive disorder
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 36 at risk

Adverse event: General disorders and administration site conditions - Other, specify
Serious: yes
Organ System: General disorders
Notes: Methicillin-Sensitive Staphylococcus aureus Ventricular Shunt Infection
Frequency: 1 affected / 36 at risk

Adverse event: Hydrocephalus
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 36 at risk

Adverse event: Nervous system disorders - Other, specify
Serious: yes
Organ System: Nervous system disorders
Notes: Altered Mental Status
Frequency: 1 affected / 36 at risk

Adverse event: Renal and urinary disorders - Other, specify
Serious: yes
Organ System: Renal and urinary disorders
Notes: Obstructive pyelonephritis
Frequency: 1 affected / 36 at risk

Adverse event: Respiratory, thoracic and mediastinal disorders
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Aspiration Pneumonia
Frequency: 1 affected / 36 at risk

Adverse event: Somnolence
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 36 at risk

Adverse event: Blood and lymphatic system disorders - Other, specify
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Bilateral lower extremity DVTs
Frequency: 1 affected / 36 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 36 at risk

Adverse event: Eye disorders - Other, specify
Serious: yes
Organ System: Eye disorders
Notes: L. Binocular Horizontal Diplopia
Frequency: 1 affected / 36 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 36 at risk

Adverse event: Gastritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 36 at risk

Adverse event: General disorders and administration site conditions - Other, specify
Serious: yes
Organ System: General disorders
Notes: DVT
Frequency: 1 affected / 36 at risk

Adverse event: Headache
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 36 at risk

Adverse event: Myalgia
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 36 at risk

Adverse event: Nervous system disorders - Other, specify
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 36 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 36 at risk

Adverse event: Skin/subcutaneous tissue disorders; Other, specify
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: Varicella Zoster Infection
Frequency: 1 affected / 36 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 36 at risk

Adverse event: Agitation
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 36 at risk

Adverse event: Akathisia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 36 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 9 affected / 36 at risk

Adverse event: Blood alkaline phosphatase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 36 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: Immune system disorders
Notes: Allergy to Naloxene
Frequency: 1 affected / 36 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 12 affected / 36 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 36 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 9 affected / 36 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 8 affected / 36 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 36 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 9 affected / 36 at risk

Adverse event: Ataxia
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 36 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 36 at risk

Adverse event: Bladder spasm
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 36 at risk

Adverse event: Blood bilirubin increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 36 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 36 at risk

Adverse event: Cardiac disorders - Other, specify
Serious: no
Organ System: Cardiac disorders
Notes: Tachycardia
Frequency: 3 affected / 36 at risk

Adverse event: Cardiac disorders - Other, specify
Serious: no
Organ System: Cardiac disorders
Notes: Elevated Blood Pressure
Frequency: 1 affected / 36 at risk

Adverse event: Cognitive disorder
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 36 at risk

Adverse event: Large intestinal ulcer
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 36 at risk

Adverse event: Disturbance in attention
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 36 at risk

Adverse event: Confusional state
Serious: no
Organ System: Psychiatric disorders
Frequency: 5 affected / 36 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 36 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 23 affected / 36 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 36 at risk

Adverse event: Blood creatine phosphokinase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 36 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 36 at risk

Adverse event: Cushingoid
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 36 at risk

Adverse event: Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 36 at risk

Adverse event: Delirium
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 36 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 36 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 36 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 12 affected / 36 at risk

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 36 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 36 at risk

Adverse event: Small intestinal haemorrhage
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 36 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 36 at risk

Adverse event: Dysmenorrhoea
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 36 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 36 at risk

Adverse event: Dysphagia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 36 at risk

Adverse event: Aphasia
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 36 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 36 at risk

Adverse event: Ear and labyrinth disorders - Other, specify
Serious: no
Organ System: Ear and labyrinth disorders
Notes: Muffled hearing
Frequency: 1 affected / 36 at risk

Adverse event: Ear and labyrinth disorders - Other, specify
Serious: no
Organ System: Ear and labyrinth disorders
Notes: Ear Wax Buildup
Frequency: 1 affected / 36 at risk

Adverse event: Ear and labyrinth disorders - Other, specify
Serious: no
Organ System: Ear and labyrinth disorders
Notes: Left Ear Dryness
Frequency: 1 affected / 36 at risk

Adverse event: Ear and labyrinth disorders - Other, specify
Serious: no
Organ System: Ear and labyrinth disorders
Notes: Right Ear Skin Irritation
Frequency: 1 affected / 36 at risk

Adverse event: Ear pain
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 36 at risk

Adverse event: Brain oedema
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 36 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 2 affected / 36 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 36 at risk

Adverse event: Erythema multiforme
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 36 at risk

Adverse event: External ear pain
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 36 at risk

Adverse event: Eye disorders - Other, specify
Serious: no
Organ System: Eye disorders
Notes: Right Ptosis
Frequency: 1 affected / 36 at risk

Adverse event: Eye disorders - Other, specify
Serious: no
Organ System: Eye disorders
Notes: Disconjugate Gaze
Frequency: 1 affected / 36 at risk

Adverse event: Eye disorders - Other, specify
Serious: no
Organ System: Eye disorders
Notes: Acute Infarct in Right Lentiform Nucleus
Frequency: 1 affected / 36 at risk

Adverse event: Eye disorders - Other, specify
Serious: no
Organ System: Eye disorders
Notes: L. upper eyelid stye
Frequency: 1 affected / 36 at risk

Adverse event: Eye disorders - Other, specify
Serious: no
Organ System: Eye disorders
Notes: Retinal Hemorrhage
Frequency: 1 affected / 36 at risk

Adverse event: Eye disorders - Other, specify
Serious: no
Organ System: Eye disorders
Notes: R. Homonymous Hemianopia
Frequency: 1 affected / 36 at risk

Adverse event: Eye disorders - Other, specify
Serious: no
Organ System: Eye disorders
Notes: Vision Issues
Frequency: 1 affected / 36 at risk

Adverse event: Eye disorders - Other, specify
Serious: no
Organ System: Eye disorders
Notes: Swollen Eyes
Frequency: 1 affected / 36 at risk

Adverse event: Eye infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 36 at risk

Adverse event: Facial paresis
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 36 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 36 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 27 affected / 36 at risk

Adverse event: Anal incontinence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 36 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 36 at risk

Adverse event: Flank pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 36 at risk

Adverse event: Vitreous floaters
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 36 at risk

Adverse event: Influenza like illness
Serious: no
Organ System: General disorders
Frequency: 2 affected / 36 at risk

Adverse event: Gait disturbance
Serious: no
Organ System: General disorders
Frequency: 7 affected / 36 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 36 at risk

Adverse event: Gastrointestinal disorders - Other, specify
Serious: no
Organ System: Gastrointestinal disorders
Notes: Loose Stools
Frequency: 1 affected / 36 at risk

Adverse event: General disorders and administration site conditions - Other, specify
Serious: no
Organ System: General disorders
Notes: Left Sided Neglect
Frequency: 1 affected / 36 at risk

Adverse event: General disorders and administration site conditions - Other, specify
Serious: no
Organ System: General disorders
Notes: Choking
Frequency: 1 affected / 36 at risk

Adverse event: General disorders and administration site conditions - Other, specify
Serious: no
Organ System: General disorders
Notes: Impaired balance
Frequency: 1 affected / 36 at risk

Adverse event: General disorders and administration site conditions - Other, specify
Serious: no
Organ System: General disorders
Notes: Bilateral Tinea Pedis
Frequency: 1 affected / 36 at risk

Adverse event: General disorders and administration site conditions - Other, specify
Serious: no
Organ System: General disorders
Notes: Tooth Fracture and Lip Laceration Secondary to Fall
Frequency: 1 affected / 36 at risk

Adverse event: General disorders and administration site conditions - Other, specify
Serious: no
Organ System: General disorders
Notes: Left Proximal Arm Discomfort
Frequency: 1 affected / 36 at risk

Adverse event: General disorders and administration site conditions - Other, specify
Serious: no
Organ System: General disorders
Notes: Bilateral Shoulder Pain
Frequency: 1 affected / 36 at risk

Adverse event: General disorders and administration site conditions - Other, specify
Serious: no
Organ System: General disorders
Notes: Right-sided facial cellulitis
Frequency: 1 affected / 36 at risk

Adverse event: General disorders and administration site conditions - Other, specify
Serious: no
Organ System: General disorders
Notes: Hip discomfort
Frequency: 1 affected / 36 at risk

Adverse event: General disorders and administration site conditions - Other, specify
Serious: no
Organ System: General disorders
Notes: Bowel incontinence
Frequency: 1 affected / 36 at risk

Adverse event: General disorders and administration site conditions - Other, specify
Serious: no
Organ System: General disorders
Notes: Rash in groin
Frequency: 1 affected / 36 at risk

Adverse event: General disorders and administration site conditions - Other, specify
Serious: no
Organ System: General disorders
Notes: Skin Tears on Coccyx
Frequency: 1 affected / 36 at risk

Adverse event: General disorders and administration site conditions - Other, specify
Serious: no
Organ System: General disorders
Notes: Erythematous Lesion
Frequency: 1 affected / 36 at risk

Adverse event: General disorders and administration site conditions - Other, specify
Serious: no
Organ System: General disorders
Notes: Episode of inability to walk
Frequency: 1 affected / 36 at risk

Adverse event: General disorders and administration site conditions - Other, specify
Serious: no
Organ System: General disorders
Notes: Diabetes Mellitus Type 2
Frequency: 1 affected / 36 at risk

Adverse event: General disorders and administration site conditions - Other, specify
Serious: no
Organ System: General disorders
Notes: Sleepwalking
Frequency: 1 affected / 36 at risk

Adverse event: General disorders and administration site conditions - Other, specify
Serious: no
Organ System: General disorders
Notes: Mouth Sore
Frequency: 1 affected / 36 at risk

Adverse event: General disorders and administration site conditions - Other, specify
Serious: no
Organ System: General disorders
Notes: Bad breath/hallitosis
Frequency: 1 affected / 36 at risk

Adverse event: General disorders and administration site conditions - Other, specify
Serious: no
Organ System: General disorders
Notes: Oral thrush
Frequency: 1 affected / 36 at risk

Adverse event: General disorders and administration site conditions - Other, specify
Serious: no
Organ System: General disorders
Notes: Herpes zoster
Frequency: 1 affected / 36 at risk

Adverse event: General disorders and administration site conditions - Other, specify
Serious: no
Organ System: General disorders
Notes: Right Upper Extremity Pronator Drift
Frequency: 1 affected / 36 at risk

Adverse event: General disorders and administration site conditions - Other, specify
Serious: no
Organ System: General disorders
Notes: Dysfluent speech
Frequency: 1 affected / 36 at risk

Adverse event: General disorders and administration site conditions - Other, specify
Serious: no
Organ System: General disorders
Notes: Word finding difficulty
Frequency: 1 affected / 36 at risk

Adverse event: General disorders and administration site conditions - Other, specify
Serious: no
Organ System: General disorders
Notes: Night sweats
Frequency: 1 affected / 36 at risk

Adverse event: General disorders and administration site conditions - Other, specify
Serious: no
Organ System: General disorders
Notes: Bilateral leg cramps at night
Frequency: 1 affected / 36 at risk

Adverse event: General disorders and administration site conditions - Other, specify
Serious: no
Organ System: General disorders
Notes: Numbness in R. Pinky Finger, Toes, and Left Shin
Frequency: 1 affected / 36 at risk

Adverse event: General disorders and administration site conditions - Other, specify
Serious: no
Organ System: General disorders
Notes: Increased thirst
Frequency: 1 affected / 36 at risk

Adverse event: General disorders and administration site conditions - Other, specify
Serious: no
Organ System: General disorders
Notes: Bilateral Ankle Swelling
Frequency: 1 affected / 36 at risk

Adverse event: General disorders and administration site conditions - Other, specify
Serious: no
Organ System: General disorders
Notes: Right-sided incision pain
Frequency: 1 affected / 36 at risk

Adverse event: General disorders and administration site conditions - Other, specify
Serious: no
Organ System: General disorders
Notes: Itching
Frequency: 1 affected / 36 at risk

Adverse event: General disorders and administration site conditions - Other, specify
Serious: no
Organ System: General disorders
Notes: Panic Attacks
Frequency: 1 affected / 36 at risk

Adverse event: Muscular weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 36 at risk

Adverse event: Growth retardation
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Right Hand cramping
Frequency: 1 affected / 36 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 18 affected / 36 at risk

Adverse event: Haematuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 36 at risk

Adverse event: Hiccups
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 36 at risk

Adverse event: Dysphonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 36 at risk

Adverse event: Hydrocephalus
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 36 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 36 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 36 at risk

Adverse event: Hypernatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 36 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 5 affected / 36 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 36 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 36 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 36 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 36 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 36 at risk

Adverse event: Hypophosphataemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 36 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 4 affected / 36 at risk

Adverse event: Infections and infestations - Other, specify
Serious: no
Organ System: Infections and infestations
Notes: Propionibacterium acnes infection
Frequency: 1 affected / 36 at risk

Adverse event: Infections and infestations - Other, specify
Serious: no
Organ System: Infections and infestations
Notes: Hepatitis
Frequency: 1 affected / 36 at risk

Adverse event: Infections and infestations - Other, specify
Serious: no
Organ System: Infections and infestations
Notes: Viral Infection
Frequency: 1 affected / 36 at risk

Adverse event: Infections and infestations - Other, specify
Serious: no
Organ System: Infections and infestations
Notes: Cold
Frequency: 1 affected / 36 at risk

Adverse event: Infections and infestations - Other, specify
Serious: no
Organ System: Infections and infestations
Notes: Rash
Frequency: 1 affected / 36 at risk

Adverse event: Injury, poisoning and procedural complications - Other, specify
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Abrasion
Frequency: 1 affected / 36 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 12 affected / 36 at risk

Adverse event: Haemorrhage intracranial
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 36 at risk

Adverse event: Investigations - Other, specify
Serious: no
Organ System: Investigations
Notes: Swollen gums
Frequency: 1 affected / 36 at risk

Adverse event: Investigations - Other, specify
Serious: no
Organ System: Investigations
Notes: Suture Wound
Frequency: 1 affected / 36 at risk

Adverse event: Investigations - Other, specify
Serious: no
Organ System: Investigations
Notes: Rash
Frequency: 1 affected / 36 at risk

Adverse event: Investigations - Other, specify
Serious: no
Organ System: Investigations
Notes: Neutropenia
Frequency: 1 affected / 36 at risk

Adverse event: Investigations
Serious: no
Organ System: Investigations
Notes: Cold-like symptpms
Frequency: 1 affected / 36 at risk

Adverse event: Investigations - Other, specify
Serious: no
Organ System: Investigations
Notes: Numbness
Frequency: 1 affected / 36 at risk

Adverse event: Investigations - Other, specify
Serious: no
Organ System: Investigations
Notes: Elevated d-dimer
Frequency: 1 affected / 36 at risk

Adverse event: Investigations - Other, specify
Serious: no
Organ System: Investigations
Notes: Tachycardia
Frequency: 1 affected / 36 at risk

Adverse event: Investigations - Other, specify
Serious: no
Organ System: Investigations
Notes: Skin abscess
Frequency: 1 affected / 36 at risk

Adverse event: Investigations - Other, specify
Serious: no
Organ System: Investigations
Notes: L. Paravertebral Discomfort
Frequency: 1 affected / 36 at risk

Adverse event: Investigations - Other, specify
Serious: no
Organ System: Investigations
Notes: Benign Prostatic Hyperplasia
Frequency: 1 affected / 36 at risk

Adverse event: Investigations - Other, specify
Serious: no
Organ System: Investigations
Notes: Word Finding Difficulty
Frequency: 1 affected / 36 at risk

Adverse event: Investigations - Other, specify
Serious: no
Organ System: Investigations
Notes: R. Lower Facial Drooping
Frequency: 1 affected / 36 at risk

Adverse event: Investigations - Other, specify
Serious: no
Organ System: Investigations
Notes: Lymphopenia
Frequency: 1 affected / 36 at risk

Adverse event: Investigations - Other, specify
Serious: no
Organ System: Investigations
Notes: Rigors
Frequency: 1 affected / 36 at risk

Adverse event: Investigations - Other, specify
Serious: no
Organ System: Investigations
Notes: Intermittent Left Upward Drift
Frequency: 1 affected / 36 at risk

Adverse event: Investigations - Other, specify
Serious: no
Organ System: Investigations
Notes: Intermittent L. Foot Pain
Frequency: 1 affected / 36 at risk

Adverse event: Investigations - Other, specify
Serious: no
Organ System: Investigations
Notes: Intermittent Pruritus on Arms and Groin
Frequency: 1 affected / 36 at risk

Adverse event: Investigations - Other, specify
Serious: no
Organ System: Investigations
Notes: Eosinophilia
Frequency: 1 affected / 36 at risk

Adverse event: Investigations - Other, specify
Serious: no
Organ System: Investigations
Notes: Stomach Cramping
Frequency: 1 affected / 36 at risk

Adverse event: Investigations - Other, specify
Serious: no
Organ System: Investigations
Notes: Upward Left Pronator Drift
Frequency: 1 affected / 36 at risk

Adverse event: Investigations - Other, specify
Serious: no
Organ System: Investigations
Notes: Worsened Elevated Blood Bilirubin
Frequency: 1 affected / 36 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 1 affected / 36 at risk

Adverse event: Leukocytosis
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 36 at risk

Adverse event: Lip infection (cold sore)
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 36 at risk

Adverse event: Localised oedema
Serious: no
Organ System: General disorders
Frequency: 1 affected / 36 at risk

Adverse event: Lymphocyte count decreased
Serious: no
Organ System: Investigations
Frequency: 10 affected / 36 at risk

Adverse event: Memory impairment
Serious: no
Organ System: Nervous system disorders
Frequency: 12 affected / 36 at risk

Adverse event: Mucosal infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 36 at risk

Adverse event: Hemiparesis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 36 at risk

Adverse event: Muscular weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 36 at risk

Adverse event: Hemiparesis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 36 at risk

Adverse event: Musculoskeletal and connective tissue disorder - Other, specify
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Joint Pain
Frequency: 1 affected / 36 at risk

Adverse event: Musculoskeletal and connective tissue disorder - Other, specify
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Generalized Pain
Frequency: 1 affected / 36 at risk

Adverse event: Musculoskeletal and connective tissue disorder - Other, specify
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Right hand cramping
Frequency: 1 affected / 36 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 36 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 36 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 18 affected / 36 at risk

Adverse event: Neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 36 at risk

Adverse event: Nervous system disorders - Other, specify
Serious: no
Organ System: Nervous system disorders
Notes: Lightheadedness
Frequency: 1 affected / 36 at risk

Adverse event: Nervous system disorders - Other, specify
Serious: no
Organ System: Nervous system disorders
Notes: Difficulty Initiating Motor Movements
Frequency: 1 affected / 36 at risk

Adverse event: Nervous system disorders - Other, specify
Serious: no
Organ System: Nervous system disorders
Notes: Right facial weakness
Frequency: 1 affected / 36 at risk

Adverse event: Nervous system disorders - Other, specify
Serious: no
Organ System: Nervous system disorders
Notes: Migraine
Frequency: 1 affected / 36 at risk

Adverse event: Nervous system disorders - Other, specify
Serious: no
Organ System: Nervous system disorders
Notes: Jaw weakness
Frequency: 1 affected / 36 at risk

Adverse event: Nervous system disorders - Other, specify
Serious: no
Organ System: Nervous system disorders
Notes: Unable to ambulate-unsteady gait
Frequency: 1 affected / 36 at risk

Adverse event: Nervous system disorders - Other, specify
Serious: no
Organ System: Nervous system disorders
Notes: Word Finding Difficulty
Frequency: 1 affected / 36 at risk

Adverse event: Nervous system disorders - Other, specify
Serious: no
Organ System: Nervous system disorders
Notes: Word Finding Difficulty
Frequency: 2 affected / 36 at risk

Adverse event: Nervous system disorders - Other, specify
Serious: no
Organ System: Nervous system disorders
Notes: Olfactory seizure activity
Frequency: 1 affected / 36 at risk

Adverse event: Nervous system disorders - Other, specify
Serious: no
Organ System: Nervous system disorders
Notes: Radicular Nerve Pain
Frequency: 1 affected / 36 at risk

Adverse event: Nervous system disorders - Other, specify
Serious: no
Organ System: Nervous system disorders
Notes: Expressive aphasia
Frequency: 1 affected / 36 at risk

Adverse event: Nervous system disorders - Other, specify
Serious: no
Organ System: Nervous system disorders
Notes: Intraparenchymal Hemorrhage
Frequency: 1 affected / 36 at risk

Adverse event: Hemiparesis
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 36 at risk

Adverse event: Neuralgia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 36 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Frequency: 8 affected / 36 at risk

Adverse event: Non-cardiac chest pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 36 at risk

Adverse event: Nystagmus
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 36 at risk

Adverse event: Obesity
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 36 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 3 affected / 36 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 36 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 36 at risk

Adverse event: Rash pustular
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 36 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 36 at risk

Adverse event: Paronychia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 36 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Frequency: 12 affected / 36 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 36 at risk

Adverse event: Psychiatric disorders - Other, specify
Serious: no
Organ System: Psychiatric disorders
Notes: Hypomania
Frequency: 1 affected / 36 at risk

Adverse event: Psychiatric disorders - Other, specify
Serious: no
Organ System: Psychiatric disorders
Notes: PTSD
Frequency: 1 affected / 36 at risk

Adverse event: Psychiatric disorders - Other, specify
Serious: no
Organ System: Psychiatric disorders
Notes: Mood alteration
Frequency: 1 affected / 36 at risk

Adverse event: Dermatitis acneiform
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 36 at risk

Adverse event: Rash maculo-papular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 36 at risk

Adverse event: Renal and urinary disorders - Other, specify
Serious: no
Organ System: Renal and urinary disorders
Notes: Difficulty urinating
Frequency: 1 affected / 36 at risk

Adverse event: Renal and urinary disorders - Other, specify
Serious: no
Organ System: Renal and urinary disorders
Notes: Nocturia
Frequency: 1 affected / 36 at risk

Adverse event: Renal and urinary disorders - Other, specify
Serious: no
Organ System: Renal and urinary disorders
Notes: Chronic Renal Insufficiency
Frequency: 1 affected / 36 at risk

Adverse event: Renal and urinary disorders - Other, specify
Serious: no
Organ System: Renal and urinary disorders
Notes: Urine Odor
Frequency: 1 affected / 36 at risk

Adverse event: Seizure
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 36 at risk

Adverse event: Sinus bradycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 5 affected / 36 at risk

Adverse event: Sinus pain
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 36 at risk

Adverse event: Sinus tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 36 at risk

Adverse event: Skin/subcutaneous tissue disorders; Other, specify
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Asteatotic Eczema on Left Lower Leg
Frequency: 1 affected / 36 at risk

Adverse event: Skin/subcutaneous tissue disorders; Other, specify
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Livedo Reticularis
Frequency: 1 affected / 36 at risk

Adverse event: Skin/subcutaneous tissue disorders; Other, specify
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Right Eyelid Erythema
Frequency: 1 affected / 36 at risk

Adverse event: Skin/subcutaneous tissue disorders; Other, specify
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: basal cell carcinoma on nose
Frequency: 1 affected / 36 at risk

Adverse event: Skin/subcutaneous tissue disorders; Other, specify
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Pruritic Rash
Frequency: 1 affected / 36 at risk

Adverse event: Skin/subcutaneous tissue disorders; Other, specify
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Fungal Infection (ringworm)
Frequency: 1 affected / 36 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 36 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 36 at risk

Adverse event: Tinnitus
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 2 affected / 36 at risk

Adverse event: Tremor
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 36 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 36 at risk

Adverse event: Pollakiuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 36 at risk

Adverse event: Urinary incontinence
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 36 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 36 at risk

Adverse event: Urinary tract pain
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 36 at risk

Adverse event: Urticaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 36 at risk

Adverse event: Presyncope
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 36 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 36 at risk

Adverse event: Lacrimation increased
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 36 at risk

Adverse event: Weight increased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 36 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 5 affected / 36 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Frequency: 11 affected / 36 at risk

Adverse event: Right hemianopsia
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 36 at risk

Adverse event: Myoglobin increase
Serious: no
Organ System: Investigations
Frequency: 1 affected / 36 at risk