Study: NCT01760876

Adverse event: Non-cardiac death from fall
Serious: yes
Organ System: Nervous system disorders
Notes: Patient slipped and fell; admitted on 11 NOV 2013 with severe head injury (closed fracture of skill vault, cerebral contusion, subdural haematoma and subarachnoid hemorrhage). Patient died on 3 Dec 2013. (non-cardiac death - not related to MACE)
Frequency: 1 affected / 30 at risk

Adverse event: Admitted for "chest pain" in between 9 months
Serious: yes
Organ System: Cardiac disorders
Notes: All 2 patients had no enzyme changes and no study-stent related ischaemia or infarct. All 2 patients discharged.
Frequency: 2 affected / 104 at risk

Adverse event: Admitted with left side numbness / stroke
Serious: yes
Organ System: Nervous system disorders
Notes: Not cardiac related. MRI scheduled. Discharged.
Frequency: 1 affected / 104 at risk

Adverse event: Admitted for upper gastrointestinal bleeding
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Endoscopy performed. Treated and discharged.
Frequency: 1 affected / 104 at risk

Adverse event: Admitted for shortness of breath
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: No cause found. Discharged.
Frequency: 2 affected / 104 at risk

Adverse event: Admitted for chest infection
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Chest infection treated with antibiotics; all discharged.
Frequency: 1 affected / 104 at risk

Adverse event: Admitted for Colonoscopy
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Colonoscopy with polyps removed.
Frequency: 2 affected / 104 at risk

Adverse event: Admitted for epistaxis
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Treatment and discharged.
Frequency: 1 affected / 104 at risk

Adverse event: Admitted for epileptic attack
Serious: yes
Organ System: Nervous system disorders
Notes: Treated and discharged.
Frequency: 1 affected / 104 at risk

Adverse event: Admitted for Hematoma at Vascular Femoral Access Site
Serious: yes
Organ System: Vascular disorders
Notes: Anticoagulation and discharged.
Frequency: 1 affected / 104 at risk

Adverse event: Admitted for Acute Dermatitis
Serious: yes
Organ System: Reproductive system and breast disorders
Notes: Admitted for penile and scrotal swelling. Treated by antibiotic and seen by surgeon. Discharged.
Frequency: 1 affected / 104 at risk

Adverse event: Admitted for low back pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Seen by orthopaedic surgeon and discharged.
Frequency: 1 affected / 104 at risk

Adverse event: Admitted for Acute Traumatic Closed Fracture of Left Foot
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Admitted for fractured bone (left calcaneum). Seen by orthopaedic surgeon and discharged.
Frequency: 1 affected / 104 at risk

Adverse event: Admitted for skin rashes, lower limb oedema
Serious: yes
Organ System: Renal and urinary disorders
Notes: DM proteinuria in one patient. Two others mild oedema not having any overt heart failure. All discharged.
Frequency: 1 affected / 104 at risk

Adverse event: 3 cases of in-stent restenosis at 9 months follow-up
Serious: yes
Organ System: Cardiac disorders
Notes: 3 patients had in-stent restenosis of the BioFreedom study stent at 9 months follow-up and treated by another DES (RI). All discharged.
Frequency: 3 affected / 104 at risk

Adverse event: Admitted for Non-target Lesion Revascularization
Serious: yes
Organ System: Cardiac disorders
Notes: Non-study lesion stented with BF stent shown ISR. Stented with ONYX.
Frequency: 1 affected / 104 at risk

Adverse event: Admitted For Atypical Chest Pain
Serious: yes
Organ System: Investigations
Notes: Non-exertional. No evidence of disorders. Discharged.
Frequency: 1 affected / 104 at risk

Adverse event: Admitted For Fluid Retention
Serious: yes
Organ System: Renal and urinary disorders
Notes: 24 hrs urine test done. Urine creatinine 2747, urine protein 5.48, Ur Prot/Ur Crea 346. Treated with ointment, diprosone oint. Skin condition improved
Frequency: 1 affected / 104 at risk

Adverse event: Admitted For Lower Leg Oedema
Serious: yes
Organ System: Renal and urinary disorders
Notes: Provincial diagnosis: Nephrotic syndrome, possible charcot arthropathy. Increased ramipril 5mg bd, decreased metformin and fludrocortisone
Frequency: 1 affected / 104 at risk

Adverse event: Admitted For Palpitation
Serious: yes
Organ System: Investigations
Notes: ECG revealed no ischemic changes. Physical examination and blood result were unremarkable. Blood pressure on high side was noted. Iosartan was increased to 25mg daily. Patient was stable and discharged home.
Frequency: 1 affected / 104 at risk

Adverse event: Admitted For Upper Respiratory Tract Infection
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: The viral antigen detection (immunofluorescence) shown influenza B was positive.
Frequency: 1 affected / 104 at risk

Adverse event: Admitted For Urinary Tract Infection
Serious: yes
Organ System: Renal and urinary disorders
Notes: Shortness of breath, cough, sputum, dizziness. Given augmentin IV. Discharged.
Frequency: 1 affected / 104 at risk

Adverse event: Admitted For NSTEMI
Serious: yes
Organ System: Cardiac disorders
Notes: E admission on 14 Aug 2013 for chest pain. Trop. I 0.97ng/mL. Successful PCI to distal LM/ostial LAD lesion.
Frequency: 1 affected / 104 at risk

Adverse event: Admitted For Pyrexia of Unknown Origin
Serious: yes
Organ System: Investigations
Notes: PET CT done and shown hypermetabolic para-aortoic LN. Blood culture and EMU for AFB negative. Impression was transient viral infection.
Frequency: 1 affected / 104 at risk

Adverse event: Admitted For Biliary Stone At Common Bile Duct
Serious: yes
Organ System: Hepatobiliary disorders
Notes: The impression was post-cholecystectomy and CBD stone noted impacted at liver hilum by ultrasound. Patient was done the ERCP and found 3 large stones in the common duct. Discharged.
Frequency: 1 affected / 104 at risk