Experience of any serious adverse events during the study
Demography
Date of birth
date
Gender
integer
Race
integer
Weight
float
Height
integer
Serious adverse events
Diagnosis or serious signs/symptoms of SAE
text
Date of onset SAE
date
Time of onset SAE
time
Maximum Intensity SAE
integer
Outcome SAE
integer
Date of resolution or death
date
Time of resolution or death
time
Investigational drug, change of dose
integer
Withdrawal
boolean
Relationship to investigational product
boolean
A serious adverse event is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalisation or prolongation of existing hospitalisation, results in disability/incapacity, or is a congenital anomaly/birth defect. 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 jeopardise 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.
boolean
Possible Causes of SAE other than lnvestigational Product(s)
Disease under study
boolean
Treatment failure
boolean
Withdrawal of investigational product(s)
boolean
Concomitant disorder
boolean
Specify concomitant disorder
text
Concomitant medication
boolean
Specify concomitant medication
text
Activity related to study participation (e.g., procedures)
boolean
Specify 'Activity related to study participation'
text
Seriousness of SAE
Death
boolean
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
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 GM2004/00133/01 CONFIDENTIAL B2E101682 41 GM2005/00011/00 serious. When in doubt as to whether “hospitalisation” occurred or was necessary, the AE should be considered serious. Hospitalisation for elective treatment of a pre-existing condition that did not worsen from baseline is not considered an AE.
boolean
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, diarrhoea, influenza, and accidental trauma (e.g. sprained ankle) which may interfere or prevent everyday life functions but do not constitute a substantial disruption.
boolean
Congenital anomaly
boolean
Specify below.
boolean
Specify, if the answer was 'other'
text
Send autopsy report if available.
boolean
Relevant Medical Conditions
Relevant Medical Conditions
text
Date of onset of medical condition
date
Condition present at time of the SAE
boolean
Date of last occurrence
date
Other relevant risk factors
Details of lnvestigational Product(s)
Day
integer
Date of dose of investigational product
date
Time of inhalation
time
Relevant Concomitant Medications
Drug Name
text
Dose of concomitant medication
float
Unit of concomitant medication
text
Frequency of concomitant medication
text
Route of concomitant medication
text
Start Date of concomitant medication
date
Concomitant medication started pre-study
boolean
Stop Date of concomitant medication
date
Concomitant Medication continued post-SAE
boolean
Reason for Concomitant Medication
text
Description of SAE
Provide a textual description of the serious adverse event (including treatment of the event).
text
Details of relevant Assessments
Provide details of other assessments (e.g., laboratory data with normal ranges) or supplemental examinations
text
Reporting lnvestigator: To the best of my knowledge, all information entered on these Serious Adverse Event pages for this subject is correct.
Reporting lnvestigator
text
Reporting lnvestigator: Address
text
Reporting lnvestigator: Signature
text
Date of report
date
Additional or follow-up information
Additional or follow-up information
text
Reporting lnvestigator: To the best of my knowledge, all information entered on these Serious Adverse Event pages for this subject is correct.
Reporting lnvestigator
text
Reporting lnvestigator: Address
text
Reporting lnvestigator: Signature
text
Date of report
date