Death Data

*The timeline requirements for this form are as follows:
Assessment Time Frame: At the time of initiation of conditioning through the D365 timepoint, or end of study participation, whichever is sooner (any ongoing AE of at least possible relatedness must be followed until resolution, death, or until the site Principal Investigator (PI) concludes that the event is stable with no further improvement anticipated). This form is required if Maximum CTCAE severity (grade) on AE Assessment form is answered Grade 5 – Fatal.
Submission Time Frame: Within 24 hours of learning of the death.

The Death Data CRF will populate if the field “Did the Subject Complete the Study” on the Study Exit / Study Completion form is answered Death. The Death Data CRF is a common form, which is available at the bottom of the subject’s page in EDC.

!All deaths, regardless of cause, must be reported for subjects on study and for deaths occurring within 30 days of last study evaluation, whichever is longer. Submit death summaries and/or autopsy reports when SAE is Fatal along with the AE form reported through SAE in study EDC. In addition to this CRF, study site must also complete all follow up forms through date of death and Study Exit / Study Completion CRF.

Date of Death:
Report the date of death in in DD/MMM/YYYY format.

Was autopsy performed?:
Report if an autopsy was performed as “Yes,” “No,” or “Unknown.”

Autopsy date:
This form appears if “Was autopsy performed?” is answered Yes. Report the autopsy date in DD/MMM/YYYY format.

Primary cause of death:
Report the underlying cause of death. According to the Centers for Disease Control and Prevention, National Center for Health Statistics, the underlying cause of death is “the disease or injury that initiated the chain of events that led directly or inevitably to death.” Report only one primary cause of death.

Select the primary cause of death from the following options:
• Recurrence / persistence / progression of disease
• Acute GVHD
• Chronic GVHD
• Graft rejection or failure
• Cytokine release syndrome (CRS)
• Infection, organism not identified
• Bacterial infection
• Fungal infection
• Viral infection
• COVID-19 (SARS-CoV-2)
• Protozoal infection
• Other infection, specify
• Idiopathic pneumonia syndrome (IPS)
• Interstitial pneumonitis (IPn)
• Diffuse alveolar damage (without hemorrhage)
• Adult respiratory distress syndrome (ARDS) (other than IPS/IPn)
• Pneumonitis due to cytomegalovirus (CMV)
• Pneumonitis due to other virus
• Other pulmonary syndrome (excluding pulmonary hemorrhage), specify
• Liver failure (not VOD)
• Veno-occlusive disease (VOD) / sinusoidal obstruction syndrome (SOS)
• Cardiac failure
• Pulmonary failure
• Central nervous system (CNS) failure
• Renal failure
• Gastrointestinal (GI) failure (not liver)
• Multiple organ failure, specify
• Other organ failure, specify
• New malignancy, specify
• Prior malignancy
• Pulmonary hemorrhage
• Diffuse alveolar hemorrhage (DAH)
• Intracranial hemorrhage
• Gastrointestinal hemorrhage
• Hemorrhagic cystitis
• Other hemorrhage, specify
• Thromboembolic
• Disseminated intravascular coagulation (DIC)
• Thrombotic microangiopathy (TMA) (thrombotic thrombocytopenic purpura (TTP)/hemolytic uremic syndrome (HUS))
• Other vascular, specify
• Other cause, specify

NOTE: Options ending in “…specify” require additional specification (up to 250 characters) in the Specify field below. Information reported in the “Specify” field must pertain to the option selected (e.g., an infectious cause of death should be specified for “Other infection”). If the primary cause of death is unclear, consult with a physician for their best medical opinion.

Specify:
This field will appear if any “…specify” option is selected above for Primary cause of death. Report the primary cause of death in the free textbox (up to 250 characters). Information reported must pertain to the option selected (e.g., an infectious cause of death should be specified for “Other infection”).

Contributing causes of death

Each contributing cause should be logged independently. This CRF allows for a maximum of 6 contributing causes. The primary cause should not be reported in this section.

Contributing cause of death:
Report each contributing cause of death. All contributing causes of death are critical to analysis of patient outcomes. If the contributing cause of death is not listed, select “Other cause, specify” and report the contributing cause in the field below.

Select the most appropriate contributing cause of death from the following options:
• Recurrence / persistence / progression of disease for which cellular therapy was performed
• Acute GVHD
• Chronic GVHD
• Graft rejection or failure
• Cytokine release syndrome (CRS)
• Infection, organism not identified
• Bacterial infection
• Fungal infection
• Viral infection
• COVID-19 (SARS-CoV-2)
• Protozoal infection
• Other infection, specify
• Idiopathic pneumonia syndrome (IPS)
• Interstitial pneumonitis (IPn)
• Diffuse alveolar damage (without hemorrhage)
• Adult respiratory distress syndrome (ARDS) (other than IPS/IPn)
• Pneumonitis due to Cytomegalovirus (CMV)
• Pneumonitis due to other virus
• Other pulmonary syndrome (excluding pulmonary hemorrhage), specify
• Liver failure (not VOD)
• Veno-occlusive disease (VOD) / sinusoidal obstruction syndrome (SOS)
• Cardiac failure
• Pulmonary failure
• Central nervous system (CNS) failure
• Renal failure
• Gastrointestinal (GI) failure (not liver)
• Multiple organ failure, specify
• Other organ failure, specify
• New malignancy, specify
• Prior malignancy
• Pulmonary hemorrhage
• Diffuse alveolar hemorrhage (DAH)
• Intracranial hemorrhage
• Gastrointestinal hemorrhage
• Hemorrhagic cystitis
• Other hemorrhage, specify
• Thromboembolic
• Disseminated intravascular coagulation (DIC)
• Thrombotic microangiopathy (TMA) (Thrombotic thrombocytopenic purpura (TTP)
• Hemolytic Uremic Syndrome (HUS))
• Other vascular, specify
• Accidental death, specify
• Suicide
• Other cause, specify

Specify:
This field will appear if any “…specify” option is selected above for Contributing cause of death. Report the contributing cause of death in the free textbox (up to 250 characters). Information reported must pertain to the option selected (e.g., an infectious cause of death should be specified for “Other infection”).

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