Adverse Events are logged on a common form, which is available at the bottom of the subject’s page in EDC. Click +New to log a new event. Please reference protocol section 8.7 to determine what events meet reporting requirements per protocol. This form allows for up to 300 events.
Adverse Event Term:
Document the adverse event term (up to 200 characters).
Please provide a succinct diagnostic term that encompasses the AE/SAE (i.e., bacteremia, back pain, encephalopathy, etc.).
The investigator should attempt to establish a diagnosis of the event based on signs, symptoms, and/or other clinical information. The diagnosis (NOT the individual signs/symptoms/test results) will be documented as the AE/SAE.
One event term should be reported per form. If multiple adverse events meeting protocol reporting requirements occur, each adverse event should be reported separately.
Medical conditions present at baseline that worsen in intensity or frequency during the course of the study should be considered and recorded as AEs/SAEs in the EDC.
Adverse event description:
Describe the pertinent information regarding the course of the AE/SAE (up to 500 characters). Do not include any protected health information (PHI).
Adverse event date of onset:
Enter the onset date of the adverse event in DD/MMM/YYYY format. This should align with the onset of symptoms.
For SAEs, please report the onset date as the date the adverse event met SERIOUS criteria. For non-serious AEs, please report the onset date as the date the adverse event met reporting criteria (i.e. CTCAE Grade 3-5).
Date site became aware of the event:
Enter the date of which the site became aware of the adverse event in DD/MMM/YYYY format. This should be the earliest business day a study team member (on the Delegation of Authority log) learns of the event. Documentation supporting date of site awareness should be documented for source data verification.
Serious Adverse Events must be reported within 24 hours of site awareness.
Max CTCAE severity (grade):
The Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 is used to classify the adverse event severity. The severity refers to the intensity of the reported event. More information on the CTCAE can be found on the National Cancer Institute website.
The maximum (or most severe) CTCAE grade should be reported for each AE. Grade refers to the severity of the AE. The CTCAE provides unique clinical descriptions for specific event severity grades. For any term that is not specifically listed in the CTCAE scale, the severity will be assigned a grade using the following general guideline:
- 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
If an AE decreases in severity prior to resolution, the maximum CTCAE should remain the reported grade and date first reached on the Adverse Events CRF.
If an AE worsens in severity prior to resolution, update the max CTCAE severity grade to reflect the new severity, ensuring the Date maximum CTCAE severity grade first reached is updated accordingly.
If a non-serious AE worsens in severity such that it meets serious criteria, please maintain the maximum severity reported for the non-serious AE and report a NEW event to reflect the onset of the serious adverse event with the new corresponding severity grading.
Date maximum CTCAE severity grade first reached:
Enter the date of which the maximum CTCAE severity was first reached in DD/MMM/YYYY format. If the maximum severity grade was reached multiple times, report the first date this was reached.
What is the relationship between the reported adverse event to post-transplant Cyclophosphamide:
What is the relationship between the reported adverse event to Tacrolimus:
What is the relationship between the reported adverse event to MMF:
What is the relationship between the reported adverse event to Abatacept:
What is the relationship between the reported adverse event to Ruxolitinib:
Indicate the relationship (attribution) between the reported adverse event and the study procedure(s)/treatment. Relationship options include:
- Definite – The AE is clearly related to the study procedure/treatment(s).
- Probable – The AE is likely related to the study procedure/treatment(s).
- Possible – The AE may be related to the study procedure/treatment(s).
- Unlikely – The AE is doubtfully related to the study procedure/treatment(s).
- Unrelated – The AE is clearly NOT related to the study procedure.
- N/A – not administered
Please provide alternate etiology, if applicable:
If unrelated to investigative drug(s), please provide alternative etiology (i.e., conditioning regimen, mismatched unrelated donor transplant, medical history, concomitant medication, social factors, etc.) in the free text box (up to 200 characters). If a concomitant medication is considered the cause of the SAE, please report on the Con Med form and link to this AE.
Outcome:
Indicate the type of resolution from the options below:
- Not recovered or not resolved
- Recovered or resolved
- Recovered or resolved with sequelae**
- Recovering or resolving
- Fatal***
- Death due to other event***
- Unknown
.** If recovered or resolved with sequelae, describe the sequelae of the event in the field below.
.*** If fatal or death due to other event, please also complete the following:
- Any follow-up forms through date of death
- Study Exit / Study Completion CRF
- Death Data CRF (which will populate once the Study Exit / Study Completion when CRF is saved)
If recovered or resolved with sequelae, please describe the sequelae of the event:
This field will only appear in the EDC if “Outcome?” is answered Recovered or resolved with sequelae. Describe the sequelae of the event in the free textbox (up to 200 characters).
Adverse event end date:
This field will only appear when “Outcome” does not = Not recovered or not resolved or Recovering or resolving or unknown. Enter the date of resolution 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. Ensure the adverse event outcome is updated appropriately to reflect the resolution of the event.
AEs should be followed until resolution of the event, death, or until the site Principal Investigator (PI) concludes that the event is stable with no further improvement anticipated.
Does this adverse event meet the protocol definition of a serious adverse event (SAE):
Indicate if the adverse event meets the protocol definition of a Serious Adverse Event (SAE).
An AE or suspected adverse reaction is considered “serious” if, in the view of either the Investigator or sponsor, it results in any of the following outcomes:
- Death
- Life-threatening event
- Inpatient hospitalization or prolongation of existing hospitalization
- Persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions
- Congenital anomaly/birth defect
- A significant medical condition, which, without urgent medical intervention, would lead to one of the above outcomes
Clarification on SAEs Definitions:
- “Death” should not be reported as an SAE, rather the event that resulted in death is what is required to be reported.
- “Life-threatening” means that the subject was at substantial risk of dying at the time of the adverse event. This does not include an event that might have led to death if it had occurred with greater severity.
- Complications that occur during hospitalizations are non-serious AEs. If a complication prolongs hospitalization, it is an SAE. Note that the hospital prolongation should be clearly and directly attributable to the event. If a subject’s hospitalization for transplant is prolonged past the institutional standard for hospitalization post-transplant or the expected date of discharge due to an AE, this AE would meet criteria for “prolongation of hospitalization.”
- “Inpatient hospitalization” means the subject has been formally admitted to a hospital for medical reasons, for any length of time. This may or may not be overnight. This does not refer to evaluation in an emergency department without admission to the hospital. This does not include planned inpatient hospitalizations for transplant, anticancer therapy in the absence of any other SAEs, or other elective procedures.
- Subjects undergoing HCT are frequently hospitalized after the initial transplant hospitalization. Subsequent events resulting in hospitalization should be reported as an SAE.
Rationale for causality assessment of SAE:
This section will appear if “Does this adverse event meet the protocol definition of a serious adverse event (SAE)?” is answered Yes. Report the rationale for causality assessment of SAE (up to 1000 characters). If the event is serious and considered to be at least possibly related to one of the drugs under study, please provide the investigator’s rationale for the relatedness assessment
Serious Adverse Event Criteria
This section will appear if “Does this adverse event meet the protocol definition of a serious adverse event (SAE)” is answered Yes. At least one of the following fields must be answered Yes to qualify as an SAE.
Is the adverse event associated with a congenital anomaly or birth defect?:
Report if the event resulted in a congenital anomaly or birth defect.
Did the adverse event result in persistent or significant disability or incapacity?:
Report if the event resulted in persistent or significant incapacity, or substantial disruption of the ability to conduct normal life functions.
Did the adverse event result in death?:
Report if the event resulted in death (this should be Yes if event is Grade 5).
Did the adverse event result in initial or prolonged hospitalization for the subject?:
Report if the event resulted in initial or prolonged hospitalization. Hospitalization means the subject has been formally admitted to a hospital for medical reasons, for any length of time. This may or may not be overnight. This does not refer to evaluation in an emergency department without admission to a hospital. This does not include planned inpatient hospitalization for transplant, anticancer therapy in the absence of any other SAEs, or other elective procedures.
Is the adverse event life threatening?:
Report if the event was life threatening. “Life-threatening” means that the subject was at substantial risk of dying at the time of the adverse event. This does not include an event that might have led to death if it had occurred with greater severity.
Is the adverse event a medically important event not covered by other “serious” criteria?:
Report if the event is serious and medically important for reasons not described above. The Investigator may deem an event to be medically important given the subject’s condition and treatment plan. A medically important event is a significant medical condition, which, without urgent intervention, would lead to one of the above outcomes.
Was an action involving changes to the study interventional drugs taken to treat SAE (PTCy, MMF, Tac, Aba, Rux)?:
Report if an action involving changes to the study interventional drugs was taken to treat the SAE. Examples include if study drug(s) administration was withdrawn, reduced, increased, or interrupted due to, or in treatment of, the AE. If yes, provide specific study drug and action taken below. The “Action taken with study drug(s)” section will appear if field is answered Yes.
Study Drugs are considered Post-Transplant Cyclophosphamide, Mycophenolate mofetil (MMF), Tacrolimus, Abatacept, Ruxolitinib.
Was an action not involving study interventional drug taken to treat SAE?:
Report if an action not involving changes to the study interventional drugs was taken to treat the SAE. If yes, provide specific action taken below. The “Action taken not involving study drug” section will appear if field is answered Yes.
Action taken with study drug(s)
This section appears when “Was an action involving changes to the study interventional drugs taken to treat SAE (PTCy, MMF, Tac, Aba, Rux)” is answered Yes. Select +New Section for each action taken. This section allows for up to 50 instances/actions.
Action taken:
Select the action from the applicable options.
Date action taken:
Enter the date of action taken in DD/MMM/YYYY format.
Did event improve?:
Report if the event improved by selecting “Yes” or “No.”
Was study treatment restarted:
Report if the study treatment restarted by selecting “Yes” or “No.”
Date study treatment restarted:
Enter the date study treatment restarted in DD/MMM/YYYY format.
Action taken not involving study drug
This section appears when “Was an action not involving study interventional drug taken to treat SAE” is answered Yes. Select +New Section for each action taken. This section allows for up to 50 instances/actions.
Treatment Type:
Report the treatment type as Drug or Non-Drug. Drug treatments should also be recorded in the Con Med form and linked to the applicable AE.
Specify Non-Drug Treatment:
Specify the Non-Drug Treatment (up to 200 characters)
Date Action taken (start date):
Enter the date of action taken in DD/MMM/YYYY format.
Stop Date:
Enter the stop date of action in DD/MMM/YYYY format.
Testing Relevant to SAE
This section appears when “Does this adverse event meet the protocol definition of a serious adverse event (SAE)” is answered Yes. Select +New Section for each relevant test. This section allows for up to 50 instances/tests.
Test Name:
Report the Test Name that was relevant to SAE (up to 200 characters).
Test Date:
Enter the test date in DD/MMM/YYYY format.
Test Result:
Report the test result (up to 200 characters).
Are lab ranges applicable for this result:
Report if lab ranges are applicable for this result. If Yes, enter Lab Normal Low/High below.
Lab Normal Low:
This field appears if “Are lab ranges applicable for this result” is answered Yes. Report the Lab Normal Low (up to 200 characters).
Lab Normal High:
This field appears if “Are lab ranges applicable for this result” is answered Yes. Report the Lab Normal High (up to 200 characters).
Comment:
Add any additional and relevant comments about this test (up to 500 characters).
Concomitant Medications form linking:
If a medication is given for treatment of an adverse event or is determined to be related to the adverse event, the appropriate Medications form can be linked directly to the Adverse Events form.
To add a link to a Medications form, you must first have entered the AE form to report the event. Next, on the Medication form click +Add Link under the Adverse Event heading. In the pop-up window, select the Adverse Event to link by clicking on the checkbox to the left of the Reference # then click Save.
Medical History form linking:
If a medical history condition is associated with this adverse event, the appropriate Medical History form can be linked directly to the Adverse Event form.
To add a link to a Medical History form, you must first have entered the Medical History form to report the event. Next, on the Adverse Event form click +Add Link under the Medical History heading. In the pop-up window, select the Medical History to link by clicking on the checkbox to the left of the Reference # then click Save.
Ruxolitinib Administration form linking:
If Ruxolitinib Administration (including dose reduction) is associated with this adverse event, the appropriate Ruxolitinib Administration form can be linked directly to the Adverse Event form.
To add a link to a Ruxolitinib Administration form, you must first have entered the Ruxolitinib Administration form to report the event. Next, on the Adverse Event form click +Add Link under the Ruxolitinib Administration heading. In the pop-up window, select the Ruxolitinib Administration to link by clicking on the checkbox to the left of the Reference # then click Save.
CCG v1.0 | CRF v1.3
Post your comment on this topic.