SERIOUS ADVERSE EVENT (SAE)
Person Reporting SAE
text
AEGIS Number
integer
Serious Adverse Experience
text
Specify reason(s) for considering this a serious AE. Mark all that apply
boolean
Specify reason(s) for considering this a serious AE. Mark all that apply. NOTE: The term ‘life-threatening’ in the definition of ‘serious’ refers to an event in which the subject was at risk of death at the time of the event. It does not refer to an event, which hypothetically might have caused death, if it were more severe.
boolean
Specify reason(s) for considering this a serious AE. Mark all that apply. NOTE: In general, hospitalisation signifies that the subject has been detained (usually involving at least an overnight stay) at the hospital or emergency ward for observation and/or treatment that would not have been appropriate in the physician’s office or out-patient setting. Complications that occur during hospitalisation are AEs. If a complication prolongs hospitalisation or fulfils any other serious criteria, the event is serious. When in doubt as to whether “hospitalisation” occurred or was necessary, the AE should be considered serious. Hospitalisation for elective treatment of a preexisting condition that did not worsen from baseline is not considered an AE.
boolean
Specify reason(s) for considering this a serious AE. Mark all that apply. NOTE: The term disability means a substantial disruption of a person’s ability to conduct normal life functions. This definition is not intended to include experiences of relatively minor medical significance such as uncomplicated headache, nausea, vomiting, diarrhea, influenza, and accidental trauma (e.g. sprained ankle) which may interfere or prevent everyday life functions but do not constitute a substantial disruption.
boolean
Specify reason(s) for considering this a serious AE. Mark all that apply
boolean
Specify reason(s) for considering this a serious AE. Mark all that apply. Medical or scientific judgement should be exercised in deciding whether reporting is appropriate in other situations, such as important medical events that may not be immediately life-threatening or result in death or hospitalisation but may jeopardize the subject or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition. These should also be considered serious. Examples of such events are invasive or malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that do not result in hospitalisation, or development of drug dependency or drug abuse.
text
day month year
date
00:00-23:59
time
day month year
date
00:00-23:59
time
NOTE: If subject died, please inform GSK within 24 hours and complete form D
integer
Experience Course
integer
Number of episodes
integer
INTENSITY (Maximum) Definition: MILD: Adverse Event which is easily tolerated. MODERATE: Adverse Event sufficiently discomforting to interfere with daily activity. SEVERE: Adverse Event which prevents normal everyday activities.
integer
Action Taken with Respect to Investigational Drug
integer
SAE abate
text
dosage change of study medication
text
Serious Adverse Experiences recurrence
text
Definition: NOT RELATED: The adverse event is definitely not related to the test drug. UNLIKELY: There are more likely causes and the drug is not suspected as a cause. SUSPECTED (REASONABLE POSSIBILITY): A direct cause and effect relationship between the drug and the adverse event has not been demonstrated but there is a reasonable possibility that the event was caused by the drug. PROBABLE: There is probably a direct cause and effect relationship between the adverse event and the study drug.
integer
Relationship to Investigational Drug, Assessment
integer
Another contition: eg, condition under study, intercurrent illness
text
If ‘Yes’, record details in the Concomitant Medication section and/or Healthcare Resource Utilisation form if appropriate
text
Patient withdrawn due to this specific AE
text
Relevant laboratory data
Test
text
day month year
text
Value
text
Units
text
Normal Range
text
Please provide a brief narrative description of the SAE, attaching extra pages eg. hospital discharge summary if necessary
text
Randomisation code broken
text
Randomisation Number
integer
Confirming that the above data are accurate and complete
text
day month year
date
Please PRINT Name
text
Medical Monitor’s Signature
text
Please PRINT Name
text
day month year
date