Study: NCT02695537

Adverse event: Abnormal liver funtion panel
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Elevated ALT, Elevated AST
Frequency: 1 affected / 89 at risk

Adverse event: Faecaloma
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 89 at risk

Adverse event: Hospital admission
Serious: yes
Organ System: General disorders
Frequency: 6 affected / 89 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 89 at risk

Adverse event: Dysphagia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 89 at risk

Adverse event: Increased seizure frequency
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 89 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 89 at risk

Adverse event: Pneumonia aspiration
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 89 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 89 at risk

Adverse event: Obstructive sleep apnoea syndrome
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 89 at risk

Adverse event: Rash
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 89 at risk

Adverse event: Spinal fusion for scoliosis
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 89 at risk

Adverse event: Gastrostomy tube (G-tube) placement
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 89 at risk

Adverse event: Elective endoscopy
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 89 at risk

Adverse event: Nausea
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 89 at risk

Adverse event: Abnormal CBC values
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 89 at risk

Adverse event: Abnormal liver function panel
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 8 affected / 89 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 89 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 89 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 89 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 89 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 89 at risk

Adverse event: Otitis media
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 5 affected / 89 at risk

Adverse event: Hordeolum
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 89 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 89 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 31 affected / 89 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 89 at risk

Adverse event: Loose stool
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 89 at risk

Adverse event: Gastroesophageal reflux disease (GERD)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 89 at risk

Adverse event: Hospital admission
Serious: no
Organ System: General disorders
Frequency: 1 affected / 89 at risk

Adverse event: Weight increased
Serious: no
Organ System: General disorders
Frequency: 2 affected / 89 at risk

Adverse event: Alopecia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 89 at risk

Adverse event: Concussion
Serious: no
Organ System: General disorders
Frequency: 1 affected / 89 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 89 at risk

Adverse event: Increased appetite
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 89 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 4 affected / 89 at risk

Adverse event: Malnutrition
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 89 at risk

Adverse event: Distended gallbladder
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 89 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 6 affected / 89 at risk

Adverse event: Nausea
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 11 affected / 89 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 89 at risk

Adverse event: Gastroenteritis viral
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 89 at risk

Adverse event: Tonsilitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 89 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 89 at risk

Adverse event: Ear infection
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 89 at risk

Adverse event: Tooth abscess
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 89 at risk

Adverse event: Pyrexia
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 89 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 89 at risk

Adverse event: Strep pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 89 at risk

Adverse event: Strep throat
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 89 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 89 at risk

Adverse event: Fracture (seizure-related)
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 89 at risk

Adverse event: Upper body pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Includes chest, arm, hand
Frequency: 2 affected / 89 at risk

Adverse event: Sedation
Serious: no
Organ System: Nervous system disorders
Frequency: 39 affected / 89 at risk

Adverse event: Insomnia
Serious: no
Organ System: Nervous system disorders
Frequency: 10 affected / 89 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 89 at risk

Adverse event: Sleep disorder
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 89 at risk

Adverse event: Ataxia
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 89 at risk

Adverse event: Diplopia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 89 at risk

Adverse event: Lethargy
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 89 at risk

Adverse event: Dysphagia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 89 at risk

Adverse event: Loss of motor control
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 89 at risk

Adverse event: Amnesia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 89 at risk

Adverse event: Depression/mood issues
Serious: no
Organ System: Psychiatric disorders
Frequency: 13 affected / 89 at risk

Adverse event: Behavior changes
Serious: no
Organ System: Psychiatric disorders
Frequency: 7 affected / 89 at risk

Adverse event: Homicidal thoughts
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 89 at risk

Adverse event: Urinary retention
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 89 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 89 at risk

Adverse event: Proteinuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 89 at risk

Adverse event: Heavy menstrual bleeding
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 4 affected / 89 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 89 at risk

Adverse event: Croup infectious
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 89 at risk

Adverse event: Hypoxia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 89 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 89 at risk

Adverse event: Seasonal allergies
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 89 at risk

Adverse event: Nosebleeds
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 89 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 89 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 89 at risk

Adverse event: Haematoma
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 89 at risk

Adverse event: Acne
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 89 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 89 at risk

Adverse event: Cellulitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 89 at risk

Adverse event: Ecchymosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 89 at risk

Adverse event: Ingrown toenail
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 89 at risk

Adverse event: Lacerations
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Laceration on lip
Frequency: 3 affected / 89 at risk

Adverse event: Dermatitis diaper
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 89 at risk

Adverse event: Ear tube placement
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 89 at risk

Adverse event: Port placement
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 89 at risk

Adverse event: Wisdom teeth extraction
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 89 at risk

Adverse event: Headaches
Serious: no
Organ System: Vascular disorders
Frequency: 4 affected / 89 at risk