Study: NCT01954082

Adverse event: PULMONARY AIR LEAK
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 11 affected / 313 at risk

Adverse event: Pulmonary haemorrhage
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 313 at risk

Adverse event: Pulmonary hypertension
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 313 at risk

Adverse event: RESPIRATORY DETERIORATION
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 10 affected / 313 at risk

Adverse event: Cholestasis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 313 at risk

Adverse event: Impaired gastric emptying
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 313 at risk

Adverse event: Hepatic enzyme increased
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 313 at risk

Adverse event: NEC
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 19 affected / 313 at risk

Adverse event: SPONTANEOUS INTESTINAL PERFORATION, WITHOUT NEC
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 313 at risk

Adverse event: Systemic infection
Serious: yes
Organ System: Infections and infestations
Frequency: 50 affected / 313 at risk

Adverse event: IVH
Serious: yes
Organ System: Nervous system disorders
Frequency: 31 affected / 313 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 313 at risk

Adverse event: Patent ductus arteriosus
Serious: yes
Organ System: Cardiac disorders
Frequency: 8 affected / 313 at risk

Adverse event: POOR PERFUSION OR HYPOTENSION
Serious: yes
Organ System: Cardiac disorders
Frequency: 23 affected / 313 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 14 affected / 313 at risk

Adverse event: Neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 313 at risk

Adverse event: Thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 9 affected / 313 at risk

Adverse event: Thrombocytosis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 313 at risk

Adverse event: Polyuria
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 313 at risk

Adverse event: ELEVATED CREATININE
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 3 affected / 313 at risk

Adverse event: Hyperkalaemia
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 4 affected / 313 at risk

Adverse event: Haematuria
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 313 at risk

Adverse event: Oliguria
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 11 affected / 313 at risk

Adverse event: Proteinuria
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 313 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 313 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 313 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 313 at risk

Adverse event: Cardio-respiratory arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 313 at risk

Adverse event: Pulmonary valve stenosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 313 at risk

Adverse event: ADRENAL INSUFFICENCY
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 313 at risk

Adverse event: Coagulopathy
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 313 at risk

Adverse event: ESPHOGEAL PERFORATION
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 313 at risk

Adverse event: Ileus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 313 at risk

Adverse event: Leukocytosis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 313 at risk

Adverse event: Acidosis
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 313 at risk

Adverse event: Hypercalcaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 313 at risk

Adverse event: Hyponatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 313 at risk

Adverse event: Hypernatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 313 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 4 affected / 313 at risk

Adverse event: Compartment syndrome
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 313 at risk

Adverse event: Meconium plug syndrome
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 313 at risk

Adverse event: Thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 313 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 185 affected / 313 at risk

Adverse event: Hyperbilirubinaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 67 affected / 313 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 30 affected / 313 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 31 affected / 313 at risk

Adverse event: Thrombocytosis
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 95 affected / 313 at risk

Adverse event: Polyuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 36 affected / 313 at risk

Adverse event: ELEVATED CREATININE
Serious: no
Organ System: Renal and urinary disorders
Frequency: 17 affected / 313 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Renal and urinary disorders
Frequency: 45 affected / 313 at risk

Adverse event: GLUCOSUIRA
Serious: no
Organ System: Renal and urinary disorders
Frequency: 7 affected / 313 at risk

Adverse event: Haematuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 14 affected / 313 at risk

Adverse event: Oliguria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 46 affected / 313 at risk

Adverse event: Proteinuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 14 affected / 313 at risk

Adverse event: PULMONARY AIR LEAK
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 23 affected / 313 at risk

Adverse event: Pulmonary haemorrhage
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 313 at risk

Adverse event: RESPIRATORY DETERIORATION
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 114 affected / 313 at risk

Adverse event: Cardiac failure congestive
Serious: no
Organ System: Cardiac disorders
Frequency: 20 affected / 313 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 23 affected / 313 at risk

Adverse event: Patent ductus arteriosus
Serious: no
Organ System: Cardiac disorders
Frequency: 88 affected / 313 at risk

Adverse event: POOR PERFUSION OR HYPOTENSION
Serious: no
Organ System: Cardiac disorders
Frequency: 36 affected / 313 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 11 affected / 313 at risk

Adverse event: CHOLEOSTASIS
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 36 affected / 313 at risk

Adverse event: Impaired gastric emptying
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 52 affected / 313 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 313 at risk

Adverse event: ELEVATED LIVER ENZYMERS
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 18 affected / 313 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 313 at risk

Adverse event: NEC
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 313 at risk

Adverse event: SPONTANEOUS INTESTINAL PERFORATION WITHOUT NEC
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 313 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 78 affected / 313 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 313 at risk

Adverse event: LOCAL INFECTION
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 313 at risk

Adverse event: SUPERFICIAL INFECTION
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 313 at risk

Adverse event: Systemic infection
Serious: no
Organ System: Infections and infestations
Frequency: 76 affected / 313 at risk

Adverse event: IVH
Serious: no
Organ System: Nervous system disorders
Frequency: 36 affected / 313 at risk

Adverse event: Seizure
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 313 at risk

Adverse event: STATE OF ALERTNESS
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 313 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 313 at risk

Adverse event: Skin disorder
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 313 at risk

Adverse event: Hypothermia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 313 at risk

Adverse event: Chronic respiratory disease
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 313 at risk

Adverse event: Respiratory distress
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 313 at risk

Adverse event: Haematochezia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 313 at risk

Adverse event: ESOPHOGEAL PERFORATION
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 313 at risk

Adverse event: Feeding intolerance
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 313 at risk

Adverse event: Gastritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 313 at risk

Adverse event: STRICTURES REQUIRING SURGERY
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 313 at risk

Adverse event: Acidosis
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 313 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 313 at risk

Adverse event: Hypophosphataemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 313 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 313 at risk

Adverse event: IV INFILTRATE
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 313 at risk

Adverse event: Osteopenia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 313 at risk

Adverse event: Dermatitis atopic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 313 at risk

Adverse event: SOFT TISSUE NECROSIS (UPPER LIMB)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 313 at risk

Adverse event: Thrombosis
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 313 at risk

Adverse event: GRANULATION TISSUE PROLAPSE (PENROSE DRAIN SITE)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 313 at risk

Adverse event: NASAL SEPTIC BREAKDOWN
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 313 at risk

Adverse event: PULMONARY AIR LEAK
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 319 at risk

Adverse event: Pulmonary haemorrhage
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 16 affected / 319 at risk

Adverse event: Pulmonary hypertension
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 319 at risk

Adverse event: RESPIRATORY DETERIORATION
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 11 affected / 319 at risk

Adverse event: Cholestasis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 319 at risk

Adverse event: Impaired gastric emptying
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 319 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 319 at risk

Adverse event: NEC
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 319 at risk

Adverse event: SPONTANEOUS INTESTINAL PERFORATION, WITHOUT NEC
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 20 affected / 319 at risk

Adverse event: SUPERFICIAL INFECTION
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 319 at risk

Adverse event: Systemic infection
Serious: yes
Organ System: Infections and infestations
Frequency: 34 affected / 319 at risk

Adverse event: IVH
Serious: yes
Organ System: Nervous system disorders
Frequency: 30 affected / 319 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 319 at risk

Adverse event: Bradycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 319 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 319 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 319 at risk

Adverse event: Patent ductus arteriosus
Serious: yes
Organ System: Cardiac disorders
Frequency: 13 affected / 319 at risk

Adverse event: POOR PERFUSION OR HYPOTENSION
Serious: yes
Organ System: Cardiac disorders
Frequency: 14 affected / 319 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 10 affected / 319 at risk

Adverse event: Hyperbilirubinaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 319 at risk

Adverse event: Neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 319 at risk

Adverse event: Thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 9 affected / 319 at risk

Adverse event: Hyperkalaemia
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 4 affected / 319 at risk

Adverse event: Haematuria
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 319 at risk

Adverse event: Oliguria
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 7 affected / 319 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 319 at risk

Adverse event: Skin disorder
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 319 at risk

Adverse event: SKIN CELLULITIS
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 319 at risk

Adverse event: ADRENAL INSUFFICENCY
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 319 at risk

Adverse event: Coagulopathy
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 319 at risk

Adverse event: ESPHOGEAL PERFORATION
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 319 at risk

Adverse event: Ileus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 319 at risk

Adverse event: Hepatic failure
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 319 at risk

Adverse event: Acidosis
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 319 at risk

Adverse event: Hyponatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 319 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 319 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 202 affected / 319 at risk

Adverse event: Hyperbilirubinaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 56 affected / 319 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 30 affected / 319 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 26 affected / 319 at risk

Adverse event: Thrombocytosis
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 96 affected / 319 at risk

Adverse event: Polyuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 44 affected / 319 at risk

Adverse event: ELEVATED CREATININE
Serious: no
Organ System: Renal and urinary disorders
Frequency: 16 affected / 319 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Renal and urinary disorders
Frequency: 49 affected / 319 at risk

Adverse event: GLUCOSUIRA
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 319 at risk

Adverse event: Haematuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 14 affected / 319 at risk

Adverse event: Oliguria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 46 affected / 319 at risk

Adverse event: Proteinuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 9 affected / 319 at risk

Adverse event: PULMONARY AIR LEAK
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 25 affected / 319 at risk

Adverse event: Pulmonary haemorrhage
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 319 at risk

Adverse event: RESPIRATORY DETERIORATION
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 120 affected / 319 at risk

Adverse event: Cardiac failure congestive
Serious: no
Organ System: Cardiac disorders
Frequency: 19 affected / 319 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 23 affected / 319 at risk

Adverse event: Patent ductus arteriosus
Serious: no
Organ System: Cardiac disorders
Frequency: 87 affected / 319 at risk

Adverse event: POOR PERFUSION OR HYPOTENSION
Serious: no
Organ System: Cardiac disorders
Frequency: 30 affected / 319 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 9 affected / 319 at risk

Adverse event: CHOLEOSTASIS
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 26 affected / 319 at risk

Adverse event: Impaired gastric emptying
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 46 affected / 319 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 319 at risk

Adverse event: ELEVATED LIVER ENZYMERS
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 319 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 319 at risk

Adverse event: NEC
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 319 at risk

Adverse event: SPONTANEOUS INTESTINAL PERFORATION WITHOUT NEC
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 319 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 67 affected / 319 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 10 affected / 319 at risk

Adverse event: LOCAL INFECTION
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 319 at risk

Adverse event: SUPERFICIAL INFECTION
Serious: no
Organ System: Infections and infestations
Frequency: 18 affected / 319 at risk

Adverse event: Systemic infection
Serious: no
Organ System: Infections and infestations
Frequency: 84 affected / 319 at risk

Adverse event: ABNORMAL MOVEMENTS
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 319 at risk

Adverse event: IVH
Serious: no
Organ System: Nervous system disorders
Frequency: 33 affected / 319 at risk

Adverse event: Seizure
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 319 at risk

Adverse event: STATE OF ALERTNESS
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 319 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 319 at risk

Adverse event: Skin disorder
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 319 at risk

Adverse event: OTHER
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Other (not including serious) adverse events under blood and lymphatic system disorders includes frank blood drainage from Penrose drain.
Frequency: 1 affected / 319 at risk

Adverse event: OTHER
Serious: no
Organ System: Cardiac disorders
Notes: Other (not including serious) adverse events under cardiac disorders include atrial vegetation/thrombus, femoral continuous loop complication (under perfusion right leg and great toe)
Frequency: 2 affected / 319 at risk

Adverse event: RENAL DYSFUNCTION
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 319 at risk

Adverse event: Renal failure
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 319 at risk

Adverse event: Hydronephrosis
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 319 at risk

Adverse event: Chronic respiratory disease
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 319 at risk

Adverse event: ABDOMINAL DISTENTION
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 319 at risk

Adverse event: Haematochezia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 319 at risk

Adverse event: Functional gastrointestinal disorder
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 319 at risk

Adverse event: Feeding intolerance
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 319 at risk

Adverse event: Gastritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 319 at risk

Adverse event: Gastrointestinal fistula
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 319 at risk

Adverse event: Ileus
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 319 at risk

Adverse event: Acidosis
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 319 at risk

Adverse event: Electrolyte imbalance
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 319 at risk

Adverse event: Failure to thrive
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 319 at risk

Adverse event: Hyperthyroidism
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 319 at risk

Adverse event: Hypothyroidism
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 319 at risk

Adverse event: ELEVATED 17-OH PROGESTERONE
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 319 at risk

Adverse event: Rickets
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 319 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 319 at risk

Adverse event: Hypophosphataemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 319 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 319 at risk

Adverse event: Hypernatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 319 at risk

Adverse event: Hypertriglyceridaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 319 at risk

Adverse event: IV INFILTRATE
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 319 at risk

Adverse event: Skin lesion
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 319 at risk

Adverse event: Adrenal insufficiency
Serious: no
Organ System: Endocrine disorders
Frequency: 4 affected / 319 at risk

Adverse event: Haemorrhage intracranial
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 319 at risk

Adverse event: Osteopenia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 319 at risk

Adverse event: Osteoporosis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 319 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 319 at risk