Narrative Review: Major Bleeding

Site	Patient	AE	Complication	Event date	AE code
xxx	xxx	x		xx/xx/xxxx	xxx

Demographic / Medical history

• [age] year old [gender]
• Past Medical History: [eg. VHD, anticoagulant usage, diabetes, and CAD,.../ including date]
• Past Surgical History:[including date]

Procedure

• Index Procedure Date/Time:
  • xx/xx/xxxx at xx:xx [insert date and time]
• Index Procedure Detail:
  • On xx/xx/xxxx at xx:xx [insert date and time] the subject underwent a [select surgical correction] for [select etiology].
  • Access site details
  • The site reported that there were/were not procedural complication(s).

Event

• Event:

• Site Reported Event Onset Date: xx/xx/xxxx
• Event summary:
  • Symptoms and sign: Subject presented with [sign and symptom] on xx/xx/xxxx.
  • Important characteristics of the chief complaint such as severity, site, and duration.
  • Other important symptoms related to the chief compliant.
  • Physical assessment:
  • Vital signs
  • Positive physical examinations or related negative examinations.

Laboratory data and Imaging

• Lab studies:
  • CBC, INR, and PT/PTT:

Date	Time	HGB	HTC	INR	PT/PTT
xx/xx/xxx	xx:xx
xx/xx/xxx	xx:xx
xx/xx/xxx	xx:xx

• • Other relevant laboratory tests:
    • Date/ name/ value

• ECG / date:

• ECHO / date:
• CXR / date:
• Other imaging and diagnostic tests / date:

 Consults

• Date and time of consult
• Suggested treatments

Clinical course

• Date and time of events,
• Patient condition got worse or better.

Treatment and outcome

• List of relevant medical treatments
• Out come [Discharge / Hospice / Death]