Study: NCT03541603

Adverse event: Device related infection
Serious: yes
Organ System: Infections and infestations
Notes: PICC LINE INFECTION WITH DUE TO Serious Adverse Event (SAE) associated with Peripherally Inserted Central Venous Catheter (PICC) HOSPITALIZATION
Frequency: 1 affected / 18 at risk

Adverse event: Bacteraemia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 18 at risk

Adverse event: Cardiac failure acute
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 18 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 18 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 1 affected / 18 at risk

Adverse event: Infusion site haemorrhage
Serious: no
Organ System: General disorders
Frequency: 1 affected / 18 at risk

Adverse event: Infusion site erythema
Serious: no
Organ System: General disorders
Frequency: 1 affected / 18 at risk

Adverse event: Oedema
Serious: no
Organ System: General disorders
Frequency: 1 affected / 18 at risk

Adverse event: Peripheral swelling
Serious: no
Organ System: General disorders
Frequency: 1 affected / 18 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 18 at risk

Adverse event: Cardiac failure acute
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 18 at risk

Adverse event: Extrasystoles
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 18 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 18 at risk

Adverse event: Cellulitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 18 at risk

Adverse event: Bacteraemia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 18 at risk

Adverse event: Device-related infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 18 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 18 at risk

Adverse event: Tooth abscess
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 18 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 18 at risk

Adverse event: Balance disorder
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 18 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 18 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 18 at risk

Adverse event: Asthma
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 18 at risk

Adverse event: Accidental overdose
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 18 at risk

Adverse event: Overdose
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 18 at risk

Adverse event: Heart rate increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 18 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 18 at risk

Adverse event: Body temperature increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 18 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 18 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 18 at risk

Adverse event: Device infusion issue
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 18 at risk

Adverse event: Device dislocation
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 18 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 18 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 18 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 18 at risk

Adverse event: Thrombophlebitis
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 18 at risk

Adverse event: Peripheral vein thrombosis
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 18 at risk

Adverse event: Vison blurred
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 18 at risk

Adverse event: Cardiogenic shock
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 19 at risk

Adverse event: Right ventricular failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 19 at risk

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

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

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

Adverse event: Cardiac failure acute
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 19 at risk

Adverse event: Cardiogenic shock
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 19 at risk

Adverse event: Right ventricular failure
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 19 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 19 at risk

Adverse event: Ventricular tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 19 at risk

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

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

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

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

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

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

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

Adverse event: Vascular access site pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 19 at risk

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

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 19 at risk

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

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

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

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

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

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

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

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

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

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