Serious Adverse Event (SAE) Assessment

!Note: Per protocol, reportable adverse events in this protocol are only those serious, unexpected adverse events that are directly linked to study instruments, including study specific tests, (i.e. walk speed or grip strength), or completion of the study questionnaires. Toxicities related to transplant but unrelated to the study instruments are not considered adverse events from this study and do not require study specific reporting beyond what is routinely reported in FormsNet to CIBMTR per standard practice.

SAE assessment

*SAE Time Frame: Reporting SAEs should occur as soon as possible, but no later than 24 hours of learning of the event for death or a life-threatening event; other SAEs should be reported within three working days.

Serious adverse event date of onset:
Enter the onset date of the adverse event in DD/MMM/YYYY format.

Date site became aware of event:
Enter the date when the center became aware of the adverse event in DD/MMM/YYYY format.

Does this adverse event meet the protocol definition of a serious adverse event?
Select “Yes” or “No” on the right-hand side of the screen. If “No” is selected, then query will be triggered after the form is saved. An SAE is defined as an untoward medical occurrence that results in any of the following outcomes:

• Death
• Life-threatening situation
  • i.e. with an immediate risk of death from the event as it occurred but not including an event that, had it occurred in a more serious form, might have caused death
• In-patient hospitalization or prolongation of existing hospitalization. Inpatient hospitalization comprises formal admission to a hospital for medical reasons, for any length of time, whether or not hospitalization extends overnight. Hospital admission for administration of conditioning, the investigational product, procedures required by the study protocol, or tumor related diagnostic procedures are not considered serious;
• Persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions;
• Congenital anomaly/birth defect; or
• An important medical event that requires intervention to prevent one of the above outcomes.
  

Serious adverse event outcome:
Indicate the outcome of the serious adverse event. Outcome options include:

• Death
• Life-threatening situation
• Inpatient hospitalization or prolongation of existing hospitalization
• Persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions
• Congenital anomaly/birth defect
• An important medical event that requires intervention to prevent one of the above outcomes
• Other, specify
  • If “Other, specify” is selected, specify the outcome in the text box (up to 200 characters).

Is this adverse event unexpected
Indicate if the adverse event was unexpected by selecting “Yes” or “No.” An adverse event is considered unexpected if the specificity or severity of which is not listed in the study protocol or informed consent document.

An expected AE is defined as an event listed in the protocol, informed consent documents or associated study materials. AEs that occur but are not listed may also be considered expected according to the medical judgement and agreement of Investigators (Protocol PI and study site PI) and Medical Monitors.

An unexpected AE is defined as an event that has a nature, severity, or frequency that is not consistent with the protocol, informed consent documents or associated study materials. “Unexpected,” as used in this definition, refers to an adverse experience that has not been previously observed and reported.

CTCAE System Order Class (SOC):
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, click here to be taken directly to the reference page.

Select the CTCAE system order class of the adverse event from the drop-down that best matches the adverse event.

CTCAE Term:
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, click here to be taken directly to the reference page.

Select the CTCAE term of the adverse event from the drop-down that best matches the adverse event. This question will only be enabled if the CTCAE System Order Class (SOC) is answered.

If “Other, specify” is selected, specify the outcome in the text box (up to 250 characters).

CTCAE severity (grade) (most severe):
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, click here to be taken directly to the reference page.

Select the most severe CTCAE grade for the adverse event. The CTCAE includes a grading (severity) scale for each AE term:

• Grade 1: Mild adverse event
• Grade 2: Moderate adverse event
• Grade 3: Severe adverse event
• Grade 4: Life-threatening or disabling adverse event
• Grade 5: Fatal adverse event
  

What is the relationship between the reported adverse event and study instruments/questionnaires?
Indicate the relationship (attribution) between the reported adverse event and the study procedures. Association or relatedness to the investigational product will be assessed by the study site PI as follows:

• Unrelated: The event is clearly related to other factors such as the subject’s clinical state, other therapeutic interventions, or concomitant medications.
• Unlikely: Toxicity is doubtfully related to the investigational product. The event may be attributable to other factors such as the subject’s clinical state, other therapeutic interventions, or concomitant medications.
• Possible: The event follows a reasonable temporal sequence from exposure to the investigational product, but could be attributable to other factors such as the subject’s clinical state, other therapeutic interventions, or concomitant medications.
• Probable: The event follows a reasonable temporal sequence from exposure to the investigational product and has been previously described in association with the investigational product OR cannot reasonably be attributed to other factors such as the subject’s clinical state, other therapeutic interventions, or concomitant medications.
• Definite: The event follows a reasonable temporal sequence from exposure to the investigational product, has been previously described in association with the investigational product, and cannot reasonably be attributed to the other factors such as the subject’s clinical state, other therapeutic interventions, or concomitant medications; AND the event disappears or improves with withdrawal of the investigational product and/or re-appears on re-exposure (e.g. in the event of an infusion reaction.)
  

Has this adverse event resolved at the time of this report?
Indicate if the adverse event was resolved at the time of completing the report. If the adverse event resolved, indicate “Yes” and continue with the following questions: date of resolution and type of resolution. If the adverse event did not resolve, indicate “No” and do not continue with the following question: date of resolution and type of resolution.

Date of resolution:
Enter the date when the adverse event resolved in DD/MMM/YYYY format. If the adverse event was ongoing at the time of death, the date of resolution should reflect the date of death.

Type of resolution:
Indicate the type of resolution for the adverse event. If the subject made a complete recovery from the adverse event, select “complete recovery from adverse event.” If the adverse event resolved but the subject has residual effects, select “resolved, but with residual effects.” If the subject died due to the adverse event, select “fatal adverse event.” If the subject died, but the death was unrelated to the adverse event, select “death unrelated to this adverse event.”

Upload a de-identified copy of any relevant files (e.g. laboratory results).
Upload any relevant files for the completion of this form.

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