Study: NCT02949362

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 24 at risk

Adverse event: Tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 24 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 24 at risk

Adverse event: Enteritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 24 at risk

Adverse event: Functional gastrointestinal disorder
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 24 at risk

Adverse event: Gastrointestinal hypomotility
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 24 at risk

Adverse event: Ileus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 24 at risk

Adverse event: Ileus paralytic
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 24 at risk

Adverse event: Pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 24 at risk

Adverse event: Rectal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 24 at risk

Adverse event: Short-bowel syndrome
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 24 at risk

Adverse event: Small intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 24 at risk

Adverse event: Small intestinal stenosis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 24 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 24 at risk

Adverse event: Complication associated with device
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 24 at risk

Adverse event: Hyperpyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 24 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 14 affected / 24 at risk

Adverse event: Systemic inflammatory response syndrome
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 24 at risk

Adverse event: Hepatic failure
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 24 at risk

Adverse event: Jaundice
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 24 at risk

Adverse event: Adenovirus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 24 at risk

Adverse event: Bacteraemia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 24 at risk

Adverse event: Bacterial infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 24 at risk

Adverse event: Bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 24 at risk

Adverse event: Device related infection
Serious: yes
Organ System: Infections and infestations
Frequency: 17 affected / 24 at risk

Adverse event: Enterococcal infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 24 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 24 at risk

Adverse event: Influenza
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 24 at risk

Adverse event: Metapneumovirus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 24 at risk

Adverse event: Micrococcus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 24 at risk

Adverse event: Osteomyelitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 24 at risk

Adverse event: Parainfluenzae virus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 24 at risk

Adverse event: Respiratory syncytial virus bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 24 at risk

Adverse event: Respiratory syncytial virus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 24 at risk

Adverse event: Rhinovirus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 24 at risk

Adverse event: Rotavirus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 24 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 24 at risk

Adverse event: Staphylococcal bacteraemia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 24 at risk

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 24 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 24 at risk

Adverse event: Urosepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 24 at risk

Adverse event: Viral infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 24 at risk

Adverse event: Anastomotic ulcer
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 24 at risk

Adverse event: Foot fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 24 at risk

Adverse event: Staphylococcus test positive
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 24 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 24 at risk

Adverse event: Electrolyte imbalance
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 24 at risk

Adverse event: Metabolic acidosis
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 24 at risk

Adverse event: Weight gain poor
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 24 at risk

Adverse event: Device breakage
Serious: yes
Organ System: Product Issues
Frequency: 6 affected / 24 at risk

Adverse event: Device failure
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 24 at risk

Adverse event: Device malfunction
Serious: yes
Organ System: Product Issues
Frequency: 5 affected / 24 at risk

Adverse event: Device occlusion
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 24 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 24 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 24 at risk

Adverse event: Tachypnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 24 at risk

Adverse event: Skin irritation
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 24 at risk

Adverse event: Catheter management
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 24 at risk

Adverse event: Central venous catheterisation
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 2 affected / 24 at risk

Adverse event: Superior vena cava syndrome
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 24 at risk

Adverse event: Lethargy
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 24 at risk

Adverse event: Ileus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 5 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 5 at risk

Adverse event: Device related infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 5 at risk

Adverse event: Device related sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 5 at risk

Adverse event: Viral pharyngitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 5 at risk

Adverse event: Viral upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 5 at risk

Adverse event: Weight decreased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 5 at risk

Adverse event: Electrolyte imbalance
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 5 at risk

Adverse event: Feeding intolerance
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 5 at risk

Adverse event: Device breakage
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 5 at risk

Adverse event: Device dislocation
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 5 at risk

Adverse event: Device malfunction
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 5 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 5 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 5 at risk

Adverse event: Abdominal adhesions
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 5 at risk

Adverse event: Intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 5 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 5 at risk

Adverse event: Cystitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 5 at risk

Adverse event: Device related infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 5 at risk

Adverse event: Device related sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 5 at risk

Adverse event: Gastroenteritis viral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 5 at risk

Adverse event: Metabolic acidosis
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 5 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 5 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 5 at risk

Adverse event: Post-tussive vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 5 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 5 at risk

Adverse event: Catheter site inflammation
Serious: no
Organ System: General disorders
Frequency: 1 affected / 5 at risk

Adverse event: Bronchiolitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 5 at risk

Adverse event: Cellulitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 5 at risk

Adverse event: Croup infectious
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 5 at risk

Adverse event: Escherichia urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 5 at risk

Adverse event: Rhinovirus infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 5 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 5 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 5 at risk

Adverse event: Viral upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 5 at risk

Adverse event: Blood creatine increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 5 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 5 at risk

Adverse event: Platelet count increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 5 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 5 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 5 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 5 at risk

Adverse event: Metabolic acidosis
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 5 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 5 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 5 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 5 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 5 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 5 at risk

Adverse event: Acne
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 5 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 5 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 5 at risk

Adverse event: Rash erythematous
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 5 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 19 at risk

Adverse event: Blood loss anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 19 at risk

Adverse event: Microcytic anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 19 at risk

Adverse event: Congenital megacolon
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 19 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 19 at risk

Adverse event: Duodenal ulcer
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 19 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 19 at risk

Adverse event: Ileus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 19 at risk

Adverse event: Short-bowel syndrome
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 19 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 19 at risk

Adverse event: Face oedema
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 19 at risk

Adverse event: Oedema peripheral
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 19 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 7 affected / 19 at risk

Adverse event: Bacteraemia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 19 at risk

Adverse event: Bacterial infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 19 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 19 at risk

Adverse event: Device related infection
Serious: yes
Organ System: Infections and infestations
Frequency: 9 affected / 19 at risk

Adverse event: Device related sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 19 at risk

Adverse event: Fungal infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 19 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 19 at risk

Adverse event: Gastroenteritis viral
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 19 at risk

Adverse event: Influenza
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 19 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 19 at risk

Adverse event: Staphylococcal sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 19 at risk

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 19 at risk

Adverse event: Viral infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 19 at risk

Adverse event: Viral upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 19 at risk

Adverse event: Anastomotic ulcer
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 19 at risk

Adverse event: Influenza A virus test positive
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 19 at risk

Adverse event: Electrolyte imbalance
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 19 at risk

Adverse event: Hypoalbuminaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 19 at risk

Adverse event: Hyponatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 19 at risk

Adverse event: Lactic acidosis
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 19 at risk

Adverse event: Metabolic acidosis
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 19 at risk

Adverse event: Weight gain poor
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 19 at risk

Adverse event: Superior vena cava occlusion
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 19 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 19 at risk

Adverse event: Lymphadenopathy
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 19 at risk

Adverse event: Ear pain
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 19 at risk

Adverse event: Middle ear effusion
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 19 at risk

Adverse event: Adrenal insufficiency
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 19 at risk

Adverse event: Visual impairment
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 19 at risk

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

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 19 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 19 at risk

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

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 19 at risk

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

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

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

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

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

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

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

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

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

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

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 19 at risk

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

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

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

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

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

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

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 19 at risk

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

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

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 2 affected / 19 at risk

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

Adverse event: Ill-defined disorder
Serious: no
Organ System: General disorders
Frequency: 1 affected / 19 at risk

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

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

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

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

Adverse event: Medical device site irritation
Serious: no
Organ System: General disorders
Frequency: 1 affected / 19 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 19 at risk

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

Adverse event: Food allergy
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 19 at risk

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

Adverse event: Seasonal allergy
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 19 at risk

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

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

Adverse event: Ear infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 19 at risk

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

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 19 at risk

Adverse event: Gastroenteritis viral
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 19 at risk

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

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 19 at risk

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

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 19 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 19 at risk

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

Adverse event: Respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 19 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 19 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 19 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 19 at risk

Adverse event: Gastrointestinal stoma complication
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 19 at risk

Adverse event: Infusion related reaction
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 19 at risk

Adverse event: Medication error
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 19 at risk

Adverse event: Procedural pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 19 at risk

Adverse event: Skin abrasion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 19 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 19 at risk

Adverse event: Bacterial test positive
Serious: no
Organ System: Investigations
Frequency: 3 affected / 19 at risk

Adverse event: Blood albumin decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 19 at risk

Adverse event: Blood iron decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 19 at risk

Adverse event: Blood sodium decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 19 at risk

Adverse event: Blood urine present
Serious: no
Organ System: Investigations
Frequency: 1 affected / 19 at risk

Adverse event: Body temperature increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 19 at risk

Adverse event: C-reactive protein increased
Serious: no
Organ System: Investigations
Frequency: 5 affected / 19 at risk

Adverse event: Gamma-glutamyltransferase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 19 at risk

Adverse event: Gastrointestinal stoma output increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 19 at risk

Adverse event: Haematocrit decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 19 at risk

Adverse event: Haemoglobin decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 19 at risk

Adverse event: Heart rate increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 19 at risk

Adverse event: Hepatic enzyme increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 19 at risk

Adverse event: Lipase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 19 at risk

Adverse event: Lymph node palpable
Serious: no
Organ System: Investigations
Frequency: 1 affected / 19 at risk

Adverse event: Faecal occult blood positive
Serious: no
Organ System: Investigations
Frequency: 1 affected / 19 at risk

Adverse event: Serum ferritin decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 19 at risk

Adverse event: Streptococcus test positive
Serious: no
Organ System: Investigations
Frequency: 1 affected / 19 at risk

Adverse event: Vitamin A decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 19 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 19 at risk

Adverse event: White blood cells urine positive
Serious: no
Organ System: Investigations
Frequency: 2 affected / 19 at risk

Adverse event: pH urine increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 19 at risk

Adverse event: Acidosis
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 19 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 19 at risk

Adverse event: Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 19 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 19 at risk

Adverse event: Hypochloraemia
Serious: no
Organ System: Metabolism and nutrition 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: Musculoskeletal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 19 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 19 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 19 at risk

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

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 19 at risk

Adverse event: Lethargy
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 19 at risk

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

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

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

Adverse event: Device dislocation
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 19 at risk

Adverse event: Device leakage
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 19 at risk

Adverse event: Device occlusion
Serious: no
Organ System: Product Issues
Frequency: 3 affected / 19 at risk

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

Adverse event: Attention deficit hyperactivity disorder
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 19 at risk

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

Adverse event: Haematuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 19 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 19 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 19 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 19 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 19 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 19 at risk

Adverse event: Pleuritic pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 19 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 19 at risk

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

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

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

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

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

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 19 at risk

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

Adverse event: Swelling face
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 19 at risk

Adverse event: Flushing
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 19 at risk