TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT01068717

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 27 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 27 at risk

Adverse event: Hidradenitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 27 at risk

Adverse event: Bowel movement irregularity
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 26 at risk

Adverse event: Asthenopia
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 26 at risk

Adverse event: Abnormal dreams
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 26 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 26 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 26 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 26 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 26 at risk

Adverse event: Eructation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 26 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 26 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 26 at risk

Adverse event: Vessel puncture site pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 26 at risk

Adverse event: Vessel puncture site inflammation
Serious: no
Organ System: General disorders
Frequency: 1 affected / 26 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 26 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 26 at risk

Adverse event: Eructation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 26 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 26 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 26 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 26 at risk
Study: NCT01068730

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 27 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 27 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 27 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 27 at risk

Adverse event: Vascular access complication
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 27 at risk

Adverse event: Oropharyngeal discomfort
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 27 at risk

Adverse event: Feeling of body temperature change
Serious: no
Organ System: General disorders
Frequency: 1 affected / 27 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 27 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 27 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 27 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 27 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 27 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 27 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 27 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 27 at risk

Adverse event: Vascular access complication
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 27 at risk

Adverse event: Ocular hyperaemia
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 28 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 28 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 28 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 28 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 28 at risk

Adverse event: Vascular access complication
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 28 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 27 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 27 at risk

Adverse event: Vascular access complication
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 27 at risk
Study: NCT01068743

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

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

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 24 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 24 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 24 at risk

Adverse event: Muscle strain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 24 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 24 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 24 at risk

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

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

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 24 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 24 at risk

Adverse event: Synovial cyst
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 24 at risk

Adverse event: Vessel puncture site pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 24 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 23 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 23 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 23 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 23 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 23 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 23 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 23 at risk
Study: NCT01068964

Adverse event: Conjunctival hyperaemia
Serious: no
Organ System: Eye disorders
Frequency: 26 affected / 121 at risk

Adverse event: Eye pain
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 121 at risk

Adverse event: Goitre
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 114 at risk

Adverse event: Ocular hypertension
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 114 at risk

Adverse event: Conjunctival hyperaemia
Serious: no
Organ System: Eye disorders
Frequency: 21 affected / 114 at risk

Adverse event: Eye pain
Serious: no
Organ System: Eye disorders
Frequency: 8 affected / 114 at risk
Study: NCT01069172

Adverse event: Secondary surgical intervention to reposition lens haptic
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 29 at risk

Adverse event: Zonular dehiscence requiring anterior vitrectomy
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 29 at risk

Adverse event: Elevated IOP requiring treatment
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 29 at risk

Adverse event: Elevated intraocular pressure
Serious: no
Organ System: Eye disorders
Frequency: 6 affected / 29 at risk
Study: NCT01069185

Adverse event: VAP
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Ventilator Associated Pneumonia
Frequency: 1 affected / 45 at risk
Study: NCT01069315

Adverse event: All SAEs
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 13 affected / 27 at risk

Adverse event: All other AEs
Serious: no
Organ System: Surgical and medical procedures
Frequency: 4 affected / 27 at risk

Adverse event: All SAEs
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 14 affected / 30 at risk

Adverse event: All other AEs
Serious: no
Organ System: Surgical and medical procedures
Frequency: 8 affected / 30 at risk

Adverse event: All SAEs
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 9 affected / 26 at risk

Adverse event: All SAEs
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 11 affected / 27 at risk

Adverse event: All other AEs
Serious: no
Organ System: Surgical and medical procedures
Frequency: 6 affected / 27 at risk
Study: NCT01069341

Adverse event: Foot amputation surgery pre-scheduled prior to enrollment
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Hospitalization for a diabetic foot ulcer with a foot amputation scheduled prior to enrollment, 24 days after 1st injection.
Frequency: 1 affected / 1 at risk

Adverse event: Hospitalization for congestive heart failure attributed to uncontrolled diabetes
Serious: yes
Organ System: Cardiac disorders
Notes: 2 months after 4th injection; 3 months after 4th injection: hospitalizations for CHF attributed to uncontrolled diabetes
Frequency: 1 affected / 1 at risk

Adverse event: Hospitalization for hyperkalemia and CHF, attributed to renal insufficiency
Serious: yes
Organ System: Cardiac disorders
Notes: 2 months after 5th injection: hospitalization for hyperkalemia and CHF, attributed to renal insufficiency due to uncontrolled diabetes
Frequency: 1 affected / 1 at risk

Adverse event: Hospitalization for exacerbation of CHF
Serious: yes
Organ System: Cardiac disorders
Notes: 4 months after 5th injection: hospitalization for exacerbation of CHF
Frequency: 1 affected / 1 at risk

Adverse event: Hospitalization for pleural effusion, CHF, and worsening of pre-existing foot ulcers (MRSA)
Serious: yes
Organ System: Cardiac disorders
Notes: 5 months after 5th injection: hospitalization for pleural effusion, CHF and worsening of pre-existing bilateral foot ulcers which cultures identified as MRSA
Frequency: 1 affected / 1 at risk

Adverse event: Hospitalization for chronic osteomyelitis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: 14 months after 5th injection: hospitalization for chronic osteomyelitis
Frequency: 1 affected / 1 at risk

Adverse event: Hospitalization for congestive heart failure and renal insufficiency
Serious: yes
Organ System: Renal and urinary disorders
Notes: 9 months after 3rd injection
Frequency: 1 affected / 1 at risk

Adverse event: Hospitalization for flare-up of pre-existing gastritis
Serious: yes
Organ System: Gastrointestinal disorders
Notes: 15 months after 3rd injection: hospitalization for flare-up of pre-existing gastritis
Frequency: 1 affected / 1 at risk
Study: NCT01069354

Adverse event: Contusion
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 44 affected / 101 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 37 affected / 101 at risk

Adverse event: Pain
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 48 affected / 101 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 66 affected / 101 at risk

Adverse event: Swelling
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 90 affected / 101 at risk

Adverse event: Pallor
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 101 at risk

Adverse event: Contusion
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 48 affected / 101 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 34 affected / 101 at risk

Adverse event: Pain
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 57 affected / 101 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 71 affected / 101 at risk

Adverse event: Swelling
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 92 affected / 101 at risk

Adverse event: Pallor
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 101 at risk
Study: NCT01069523

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Notes: Self report by child or parent
Frequency: 1 affected / 13 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Notes: Self report by parent or child
Frequency: 1 affected / 13 at risk

Adverse event: Sedation
Serious: no
Organ System: General disorders
Notes: Self report by parent or child
Frequency: 3 affected / 13 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Notes: Self report by child or parent
Frequency: 1 affected / 16 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Notes: Self report by parent or child
Frequency: 1 affected / 16 at risk

Adverse event: Sedation
Serious: no
Organ System: General disorders
Notes: Self report by parent or child
Frequency: 5 affected / 16 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Self report by parent or child
Frequency: 3 affected / 16 at risk
Study: NCT01069562

Adverse event: High inotropic requirement intra-op
Serious: no
Organ System: Cardiac disorders
Notes: The number of patients who required a dose ≥ 0.1 µg/kg/min of adrenaline infusion for any duration of time or addition of a second inotropic agent during cardiac surgery.
Frequency: 3 affected / 20 at risk

Adverse event: High inotropic requirement intra-op
Serious: no
Organ System: Cardiac disorders
Notes: The number of patients who required a dose ≥ 0.1 µg/kg/min of adrenaline infusion for any duration of time or addition of a second inotropic agent during cardiac surgery.
Frequency: 2 affected / 20 at risk
Study: NCT01069705

Adverse event: Infective pulmonary exacerbation of cystic fibrosis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 49 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 49 at risk

Adverse event: Haemoptysis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 49 at risk

Adverse event: Hypoacusis
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 2 affected / 49 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 49 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 49 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 49 at risk

Adverse event: Non-cardiac chest pain
Serious: no
Organ System: General disorders
Frequency: 2 affected / 49 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 49 at risk

Adverse event: Acute sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 49 at risk

Adverse event: Alcaligenes infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 49 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 49 at risk

Adverse event: Burkholderia cepacia complex infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 49 at risk

Adverse event: Infective pulmonary exacerbation of cystic fibrosis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 49 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 49 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 49 at risk

Adverse event: Respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 49 at risk

Adverse event: Respiratory tract infection viral
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 49 at risk

Adverse event: Staphylococcus test positive
Serious: no
Organ System: Investigations
Frequency: 1 affected / 49 at risk

Adverse event: Protein urine present
Serious: no
Organ System: Investigations
Frequency: 1 affected / 49 at risk

Adverse event: Bronchospasm
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 49 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 49 at risk

Adverse event: Dysphonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 49 at risk

Adverse event: Productive cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 49 at risk
Study: NCT01069861

Adverse event: Congenital pneumonia
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 4 at risk

Adverse event: Persistent foetal circulation
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 4 at risk

Adverse event: Cardiac disorder
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 4 at risk

Adverse event: Pericardial effusion
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 4 at risk

Adverse event: Infusion site erythema
Serious: no
Organ System: General disorders
Frequency: 1 affected / 4 at risk

Adverse event: Incorrect product administration duration
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 4 at risk

Adverse event: Blood lactic acid increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 4 at risk

Adverse event: C-reactive protein increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 4 at risk

Adverse event: Intraventricular haemorrhage
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 4 at risk

Adverse event: Hypoxia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 4 at risk

Adverse event: Pleural effusion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 4 at risk

Adverse event: Pneumothorax
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 4 at risk

Adverse event: Pulmonary haemorrhage
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 4 at risk

Adverse event: Respiratory distress
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 4 at risk

Adverse event: Blister
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 4 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 4 at risk
Study: NCT01070043

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 21 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 21 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 21 at risk

Adverse event: Breast cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 21 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 21 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 21 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 21 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 21 at risk
Study: NCT01070381

Adverse event: 3-grade change in symptoms (frequency and/or severity) from baseline
Serious: no
Organ System: Eye disorders
Notes: As collected on a questionnaire. Symptoms included 1 or more of the following: lens awareness, discomfort, blurred vision.
Frequency: 16 affected / 217 at risk

Adverse event: 3-grade change in symptoms (frequency and/or severity) from baseline
Serious: no
Organ System: Eye disorders
Notes: As collected on a questionnaire. Symptoms included 1 or more of the following: lens awareness, discomfort, blurred vision.
Frequency: 27 affected / 216 at risk
Study: NCT01070394

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 32 affected / 40 at risk

Adverse event: Headache
Serious: no
Organ System: Vascular disorders
Frequency: 21 affected / 40 at risk

Adverse event: Loss of Appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 21 affected / 40 at risk

Adverse event: Dry mouth
Serious: no
Organ System: General disorders
Frequency: 17 affected / 40 at risk
Study: NCT01070771

Adverse event: Vessel occlusion
Serious: yes
Organ System: Cardiac disorders
Notes: In one patient, the operator crossed a tightly stenosed right coronary artery with the pressure wire but this vessel subsequently occluded, leading to emergency PCI and a troponin rise to 5.88mcg/L.
Frequency: 1 affected / 200 at risk

Adverse event: Coronary artery dissection
Serious: yes
Organ System: Cardiac disorders
Notes: a second case, the pressure wire manipulation in the left anterior descending artery led to coronary artery dissection and the patient underwent emergency CABG surgery, which was subsequently complicated by a deep vein thrombosis.
Frequency: 1 affected / 200 at risk

Adverse event: Ventricular fibrillation
Serious: yes
Organ System: Cardiac disorders
Notes: In one patient there was an episode of ventricular fibrillation during FFR assessment of the RCA and the operator decided not to proceed to further measurements .
Frequency: 1 affected / 200 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Vascular disorders
Notes: Patient underwent emergency CABG and subsequently went on to experience DVT
Frequency: 1 affected / 200 at risk