An adverse event (AE) is any untoward medical occurrence in a clinical investigation subjects administered an investigational product; the event does not necessarily have a causal relationship with investigational product administration or usage. An adverse event can therefore be an unfavorable and unintended sign (including an abnormal laboratory finding), symptom, syndrome or disease associated with or occurring during the use of an investigational product whether or not considered related to the investigational product.
Event start date _______
Enter the date the adverse event first occurred in DD/MMM/YYYY format.
Event end date _______
Enter the date the adverse event resolved in DD/MMM/YYYY format.
N/A, event ongoing ☐
If event is still ongoing, mark this check box.
Severity
Indicate the severity of the adverse event
- Mild
- Moderate
- Severe
- Unknown
CTCAE System Order Class (SOC) (V5.0) _______ (Search List with all SOCs)
The Common Terminology Criteria for Adverse Events (CTCAE) version 5 is used to classify the adverse events. More information on the CTCAE can be found on the National Cancer Institute website, http://ctep.cancer.gov/protocolDevelopment/electronic_applications/ctc.htm..
Select the CTCAE system order class of the adverse event from the dropdown that best matches the adverse event.
CTCAE Term (V5.0) _______ (Search list with all CTCAE V5.0 Terms)
The Common Terminology Criteria for Adverse Events (CTCAE) version 5 is used to classify the adverse events. More information on the CTCAE can be found on the National Cancer Institute website, http://ctep.cancer.gov/protocolDevelopment/electronic_applications/ctc.htm..
Select the CTCAE term of the adverse event from the dropdown that best matches the adverse event.
If “Other, specify” is selected, specify the outcome in the text box (up to 100 characters).
CTCAE grade (V5.0)
Indicate the most severe grade of the adverse event.
Grade 1
Mild; asymptomatic or mild symptoms; clinical or diagnostic ovservations only; intervention not indicated.
Grade 2
Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental ADL.
Grade 3
Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL.
Grade 4
Life-threatening consequences; urgent intervention indicated.
Grade 5
Death related to AE.
Seriousness
Indicate if the adverse event meets the protocol definition of serious.
Outcome
- Recovered without sequelae
- Recovered with sequelae
- Not recovered
- Death
- Unknown
Course of event
Indicate the course of the event.
- Single episode
- Intermittent
- Continuous
Relationship to study treatment
Study treatment
Determine if the adverse event is related to each treatment listed below. Add a log line for each treatment type
- Kidney transplant
- rATG
- Radiation
- Cell infusion
- Other, specify _______
Relationship to study
Indicate the relationship to study drug.
Not related
The adverse event is clearly not related to the investigational agent(s).
Unlikely related
The adverse event is doubtfully related to the investigational agent(s).
Possibly related
The adverse event is may be related to the investigational agent(s).
Probably related
The adverse event is likely related to the investigational agent(s).
Definitely related
The adverse event is clearly related to the investigational agent(s).
CCG v.1 | CRF v.1
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