Serious Adverse Event
DEFINITION OF A SERIOUS ADVERSE EVENT (SAE) (Page 1 of 5) A serious adverse event is any untoward medical occurrence that, at any dose: a) results in death. b) is life-threatening. 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. c) requires hospitalisation or prolongation of existing hospitalisation. 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. d) results in disability/incapacity, or 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. e) is a congenital anomaly/birth defect. f) other. 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
If Yes, summarise findings in Section 11 Narrative Remarks of this SAE form.
boolean
SECTION 1
Record one SAE diagnosis per line, or a sign/symptom if the diagnosis is not available. If a diagnosis subsequently becomes available, this then should be entered and the sign/symptom crossed out, initialled and dated by the investigator. A separate form should be used for each SAE. However, if multiple SAEs which are temporally or clinically related are apparent at the time of initial reporting then these may be reported on the same page.
text
Record the start date of the first occurrence of the SAE.
date
Record the start date of the first occurrence of the SAE.
time
All SAEs must be followed until the events are resolved, the condition stabilises, the events are otherwise explained, or the subject is lost to follow-up. Indicate if the event was ’Recovered/Resolved’ or ’Recovered/Resolved with sequelae’. If the SAE is ongoing at the time the subject completes the study or becomes lost to follow-up, the outcome must be recorded as ’Not recovered/Not resolved’ or ’Recovering/Resolving’. Also enter ’Not recovered/Not resolved’ if the SAE was ongoing at the time of death, but was not the cause of death, enter fatal for the SAE which was the direct cause of death.
integer
Record the end date. This is the date the SAE Recovered/Resolved, or if the outcome was fatal, record the date the subject died. If the event Recovered/Resolved with sequelae, enter the date the subject’s medical condition resolved or stabilised. Leave blank if the SAE is ’Not recovered/Not resolved’ or ’Recovering/Resolving’.
date
Record the end time of the SAE.
time
Record the maximum intensity that occurred over the duration of the event. Amend the intensity if it increases. Mild = An event that is easily tolerated by the subject, causing minimal discomfort and not interfering with everyday activities. Moderate = An event that is sufficiently discomforting to interfere with everyday activities. Severe = An event that prevents normal everyday activities. Not applicable = Those event(s) where intensity is meaningless or impossible to determine (i.e., blindness and coma).
text
Investigational product(s) withdrawn = Administration of investigational product(s) was permanently discontinued. Dose reduced = Dose is reduced for one or more investigational product(s). Dose increased = Dose increased for one or more investigational product(s). Dose not changed = Investigational product(s) continues even though an adverse event has occurred. Dose interrupted = Administration of one or more investigational product(s) was temporarily interrupted but then restarted. Not applicable = Subject was not receiving investigational product(s) when the event occurred (e.g., pre-or post-dosing) or the subject died and there was no prior decision to discontinue IP(s).
text
Indicate ’Yes’ if the event(s) were directly responsible for the subject’s withdrawal as indicated on the Study Conclusion page, otherwise indicate ’No’. If yes: Complete Study Conclusion page and check Adverse event as reason for withdrawal.
boolean
It is a regulatory requirement for investigators to assess relationship to investigational product(s) based on information available. The assessment should be reviewed on receipt of any new information and amended if necessary. ’A reasonable possibility’ is meant to convey that there are facts/evidence or arguments to suggest a causal relationship. Facts/evidence or arguments that may support ’a reasonable possibility’ include, e.g., a temporal relationship, a pharmacologically-predicted event, or positive dechallenge or rechallenge. Confounding factors, such as concomitant medication, a concurrent illness, or relevant medical history, should also be considered.
boolean
SECTION 2: Seriousness
SAE results in death
boolean
SAE is life-threatening
boolean
SAE requires hospitalisation
boolean
SAE results in disability/incapacity
boolean
SAE: Congenital anomaly/birth defect
boolean
SAE, other
boolean
(see definition of SAE)
text
SECTION 3 Demography Data
SECTION 4 If Investigational Product(s) was Stopped, Did the Reported Event(s) Recur After Further Investigational Product(s) were Administered?
Recurrence of the reported SAE in case of discontinuation of the investigational product
text
SECTION 5 Possible Causes of SAE Other Than Investigational Product(s)
Disease under study
boolean
(record in Section 6)
boolean
Lack of efficacy
boolean
Withdrawal of investigational product(s)
boolean
(record in Section 8)
boolean
Activity related to study participation
boolean
Other, specify
text
SECTION 6 RELEVANT Medical Conditions
Relevant Medical Conditions
text
Date of onset
date
Condition Present at Time of the SAE?
boolean
Date of Last Occurrence
date
SECTION 7 Other RELEVANT Risk Factors
SECTION 8 RELEVANT Concomitant Medications
(Trade Name preferred)
text
Dose
float
Unit
text
Frequency
text
Route
text
Taken Prior to Study?
boolean
Start Date
date
Stop Date
date
Ongoing Medication?
boolean
Reason for Medication
text
SECTION 9 Details of Investigational Product(s) - Treatment Period 1
Infusion Start Date
date
Infusion Start Time
time
Infusion Stop Date
date
Infusion Stop Time
time
IV Administration Casopitant Dose
float
SECTION 9 Details of Investigational Product(s) - Treatment Period 2
Date of Dose
date
Time of Dose
time
Oral Administration Casopitant Dose
float
SECTION 10 Details of relevant Assessments
SECTION 11 Narrative Remarks
Investigator's name and signature
(confirming that the data on the SAE pages are accurate and complete)
text
(print)
text
Date
date
SECTION 12: Additional/Follow-Up Information
use this page to provide any additional details on the SAE not already captured on the previous pages
text
confirming that the data on the SAE pages are accurate and complete
text
text
Date
date