3504: Organ Function / Late Effects

The Organ Function / Late Effects (3504) form captures various organ impairments / disorders that may occur post-infusion for both transplant and cellular therapy. This form will come due, starting at Day 100, for transplant recipients randomized to the Comprehensive Report Form (CRF) track. Additionally, this form will come due, starting at one-year, for cellular therapy recipients randomized to the CRF track.

Review Table 1 and Table 2 for a summary of when this form will come due for stand-alone infusions and combined follow-up scenarios.

Depending on the infusion type, questions capturing specific organ impairments / disorders will be enabled. Review Table 3 below for more information.

Table 1. When the Organ Function / Late Effects (3504) Comes Due for Stand Alone Infusions

Infusion Type	When Form Comes Due
Stand alone cellular therapy	-Organ Function / Late Effects (3504) will come due starting at one-year post-infusion -The Cellular Therapy Essential Data Follow-Up (4100) must be completed first
Stand alone HCT	-Organ Function / Late Effects (3504) will come due starting at Day 100 post-infusion -The Post-Infusion Follow-Up (2100) must be completed first

Table 2. When the Organ Function / Late Effects (3504) Comes Due for Combined Follow-Up

Current Infusion	Prior Infusion	Starting Time Point	How Form Comes Due
CT (CRF)	HCT (CRF)	Day 100	-Day 100: Organ Function / Late Effects (3504) will come due from the Post-Infusion Follow-Up (2100) -Six months: Organ Function / Late Effects (3504) will come due the Post-Infusion Follow-Up (2100) -One year+: Organ Function / Late Effects (3504) will come due from the Post-Infusion Follow-Up (2100) or Cellular Therapy Essential Data Follow-Up (4100)
CT (TED)	HCT (CRF)	Day 100	Organ Function / Late Effects (3504) will come due once the Post-Infusion Follow-Up (2100) is completed
CT (CRF)	HCT (TED)	One year	Organ Function / Late Effects (3504) will come due once the Cellular Therapy Essential Data Follow-Up (4100) is completed, completed starting at one year
HCT (CRF)	CT (CRF)	Day 100	-Day 100: Organ Function / Late Effects (3504) will come due from the Post-Infusion Follow-Up (2100) -Six months: Organ Function / Late Effects (3504) will come due from the Post-Infusion Follow-Up (2100) -One year+: Organ Function / Late Effects (3504) will come due from the Post-Infusion Follow-Up (2100) or the Cellular Therapy Essential Data Follow-Up (4100)
HCT (TED)	CT (CRF)	One year	Organ Function / Late Effects (3504) will come due once the Cellular Therapy Essential Data Follow-Up (4100) is completed, starting at one year
HCT (CRF)	CT (TED)	Day 100	Organ Function / Late Effects (3504) will come due once the Post-Infusion Follow-Up (2100) is completed

Table 3. Organ Impairments / Disorders Enabled Based on Infusion Type

Organ Impairment / Disorder	HCT or CT
IPn or ARDS / IPS	HCT
Non-infectious pulmonary abnormality	HCT
Endotracheal intubation or mechanical ventilation	HCT
Therapy used to prevent liver toxicity	HCT
Cirrhosis	HCT and CT
Non-infectious liver toxicity	HCT
Thrombotic microangiopathy	HCT
Renal impairment / disorder	HCT and CT
Arrhythmia	HCT and CT
Cardiomyopathy	HCT and CT
Congestive heart failure	HCT and CT
Coronary artery disease	HCT and CT
Unstable angina	HCT and CT
Myocardial infarction	HCT and CT
Hypertension	HCT
Pericarditis	HCT and CT
Heart valve disease	HCT and CT
Deep vein thrombosis	HCT and CT
Pulmonary embolism	HCT and CT
Hyperlipidemia	HCT
CNS hemorrhage	HCT
Encephalopathy (non-infectious)	HCT
Neuropathy	HCT
Seizures	HCT
Stroke	HCT
Diabetes	HCT and CT
Growth hormone deficiency / short stature	HCT
Hypothyroidism	HCT and CT
Pancreatitis	HCT and CT
Hemorrhagic cystitis / hematuria	HCT
Avascular necrosis	HCT and CT
Osteonecrosis of the haw	HCT and CT
Osteoporosis	HCT and CT
Osteoporotic fracture	HCT and CT
Psychiatric impairment	HCT and CT
Cataracts	HCT
Iron overload	HCT
Mucositis	HCT
Other	HCT

Links to Sections of Form:
Q1 – 18: Pulmonary Function
Q19 – 28: Liver Function
Q29 – 39: Thrombotic Microangiopathy
Q40 – 53: Renal Impairment / Disorder
Q54 – 89: Cardiac Impairment / Disorder
Q90 – 104: Vascular Impairment / Disorder
Q105 – 118: Neurological Impairment / Disorder
Q119 – 133: Endocrine Impairment / Disorder
Q134 – 139: Genitourinary Impairment / Disorder
Q140 – 149: Musculoskeletal Impairment / Disorder
Q150 – 152: Psychiatric Impairment / Disorder
Q153 – 167: Other Impairment / Disorder
Q168 – 172: Solid Organ Transplant

Manual Updates

Sections of the Forms Instruction Manual are frequently updated. The most recent updates for the current manual version can be found below. For additional information, select the manual section and review the updated text.

To review the historical Manual Change History for this manual, reference the retired manual section on the Retired Forms Manuals webpage.

Date	Manual Section	Add/Remove/Modify	Description
4/24/2026	3504: Organ Function / Late Effects	Add	Added red warning box above question 29 to clarify the question apply only to 100d and 6 month timepoints: Thrombotic Microangiopathy (TMA) questions can only be completed on the 100-day and 6-month follow-up forms. These questions will be disabled for all subsequent reporting periods.
4/24/2026	3504: Organ Function / Late Effects	Modify	Clarified intent of reporting seizures in Q115: Seizures are sudden, involuntary muscle contractions due to hyperexcitation of neurons. Indicate if the recipient experienced a seizure(s) in the current reporting period. The intent of this question is to capture each the first instance of a seizure occurring in the reporting period. If the recipient did not have a seizure in the current reporting period or is unknown, select No.
4/24/2026	3504: Organ Function / Late Effects	Modify	Removed the Reporting Multiple Seizures blue note box and updated instructions for reporting the seizure onset date in Q116: Reporting Multiple Seizures: Complete Date of a seizure(s) onset question to report multiple seizures by adding an additional instance in the FormsNet3SM application. Specify the date of the seizure. If multiple seizures occurred in the reporting period, only the first seizure needs to be reported. If multiple seizures occurred in one day, only one instance is required to capture the seizures occurring that day; multiple instances for the same day are not required.
4/24/2026	3504: Organ Function / Late Effects	Add	Clarified intent of the successful extubation question in Q17 – 18: Indicate if the recipient was successfully extubated during the reporting period. The intent of this question is to capture if the outcome of the recipient was successful. If Yes, report the date extubated. If the recipient was extubated multiple times within the reporting period, report the last date extubated. If the recipient was not successfully extubated, passed away while intubated, or was transitioned to comfort care, select No.
4/24/2026	3504: Organ Function / Late Effects	Modify	Replaced Reporting Multiple CAD blue box with Reporting Coronary Artery Disease (CAD) red warning box above Q70: Reporting Multiple Coronary Artery Diseases: Complete Was coronary artery disease present through Date coronary artery disease onset questions to report multiple coronary artery diseases by adding an additional instance in the FormsNet3SM application. Reporting Coronary Artery Disease (CAD): Only the first instance of CAD needs to be reported. Once it has been reported that CAD Developed or Persisted post-infusion, do not continue to report it, regardless if it resolved in a prior reporting period and recurred in the current reporting period and / or was present in a prior reporting period and persisted into the current reporting period (excluding, a pre-infusion diagnosis persisting into the Day 100 (for HCT) or into the one-year reporting period (without resolution since the pre-infusion diagnosis) (for cellular therapy)).
4/24/2026	3504: Organ Function / Late Effects	Modify	Updated instructions for reporting persistent and developed in Q70: Coronary artery disease is the damage or disease in the major blood vessels of the heart. Coronary artery disease is also knowns as CAD and atherosclerotic heart disease. Indicate if coronary artery disease was present in the current reporting period. Report Developed in the following scenarios: – This is the first time the recipient was diagnosed with coronary artery disease in the reporting period. – Coronary artery disease resolved in a prior reporting period and then recurred in the current reporting period. If coronary artery disease Developed, report the onset date. If the diagnosis was determined at an outside center and no documentation of a clinical, pathological, or laboratory assessment is available, the dictated date of diagnosis within a physician note may be reported. For more information regarding reporting partial or unknown dates, see General Instructions, General Guidelines for Completing Forms Report Persisted in the following scenarios: – Coronary artery disease was diagnosed pre-infusion and persisted into the Day 100 reporting period. – Coronary artery disease was diagnosed (or persisted) in the prior reporting period and persisted into the current reporting period. – For cellular therapy, if coronary artery disease was diagnosed pre-infusion and persisted into the one-year reporting period (without resolution since the pre-infusion diagnosis) as this form will not come due until the one-year reporting period. If coronary artery disease was not present in the current reporting period or unknown if present, select Not present.
4/24/2026	3504: Organ Function / Late Effects	Add	Clarified intent of Q153 – 154 and when to report ‘not present’: Cataracts are the loss of transparency in the lens of the eye. Indicate if cataracts were present in the current reporting period. The intent of this question is only to capture the first occurrence of the impairment / disorder in the recipient’s post-infusion course. The impairment / disorder should be reported once, in the reporting period in which it first meets the criteria for reporting. After the impairment / disorder is reported once post-infusion, it should never be reported again. ; If cataracts were reported as Developed or Persisted in a prior reporting period (regardless of it recurred), not present in the current reporting period, or unknown if present, select Not present.
4/24/2026	3504: Organ Function / Late Effects	Add	Clarified intent of Q163 – 164 and when to report ‘not present’: Mucositis is the inflammation and ulceration of mucous membranes that line the digestive tract, usually due to chemotherapy and radiotherapy. Specify if mucositis was present in the current reporting period. Indicate if mucositis requiring therapy was present in the current reporting period. The intent of this question is only to capture the first occurrence of the impairment / disorder in the recipient’s post-infusion course. The impairment / disorder should be reported once, in the reporting period in which it first meets the criteria for reporting. After the impairment / disorder is reported once post-infusion, it should never be reported again. ; If mucositis was reported as Developed or Persisted in a prior reporting period (regardless of it recurred), not present in the current reporting period, or unknown if present, select Not present.
4/24/2026	3504: Organ Function / Late Effects	Add	Clarified intent of Q146 – 147 and when to report ‘not present’: Osteoporosis is where the bones become weak and brittle due to losing bone mass faster than it is created from aging. Indicate if osteoporosis was present in the current reporting period. The intent of this question is only to capture the first occurrence of the impairment / disorder in the recipient’s post-infusion course. The impairment / disorder should be reported once, in the reporting period in which it first meets the criteria for reporting. After the impairment / disorder is reported once post-infusion, it should never be reported again. ; If osteoporosis was reported as Developed or Persisted in a prior reporting period (regardless of it recurred), not present in the current reporting period or unknown if present select Not present.
4/24/2026	3504: Organ Function / Late Effects	Add	Clarified intent of Q134 – 135 and when to report ‘not present’: Gonadal dysfunction requiring hormone replacement affects both males and females. Males experience decreased spermatogenesis and females may experience early symptoms of menopause, including amenorrhea. Low levels of follicle stimulating hormone (FSH), luteinizing hormone (LH), and / or testosterone may require hormone replacement therapy. Indicate if gonadal dysfunction requiring hormone replacement was present in the current reporting period. The intent of this question is only to capture the first occurrence of the impairment / disorder in the recipient’s post-infusion course. The impairment / disorder should be reported once, in the reporting period in which it first meets the criteria for reporting. After the impairment / disorder is reported once post-infusion, it should never be reported again. ; If gonadal dysfunction requiring hormone replacement was reported as Developed or Persisted in a prior reporting period (regardless of it recurred), not present in the current reporting period, or unknown if present, select Not present.
4/24/2026	3504: Organ Function / Late Effects	Add	Clarified intent of Q125 and when to report ‘not present’: Indicate if growth hormone deficiency / short stature was present in the current reporting period. The intent of this question is only to capture the first occurrence of the impairment / disorder in the recipient’s post-infusion course. The impairment / disorder should be reported once, in the reporting period in which it first meets the criteria for reporting. After the impairment / disorder is reported once post-infusion, it should never be reported again. ; If growth hormone deficiency / short stature was reported as Developed or Persisted in a prior reporting period (regardless of it recurred), not present in the current reporting period or unknown if present, select Not present.
4/24/2026	3504: Organ Function / Late Effects	Add	Clarified intent of Q130 and when to report ‘not present’: Indicate if hypothyroidism requiring replacement therapy was present in the current reporting period. The intent of this question is only to capture the first occurrence of the impairment / disorder in the recipient’s post-infusion course. The impairment / disorder should be reported once, in the reporting period in which it first meets the criteria for reporting. After the impairment / disorder is reported once post-infusion, it should never be reported again. ; If hypothyroidism requiring replacement therapy was reported as Developed or Persisted in a prior reporting period (regardless of it recurred), not present in the current reporting period or unknown if present, select Not present.
4/24/2026	3504: Organ Function / Late Effects	Add	Clarified intent of Q132 – 133 and when to report ‘not present’: Indicate if pancreatitis were present in the current reporting period. The intent of this question is only to capture the first occurrence of the impairment / disorder in the recipient’s post-infusion course. The impairment / disorder should be reported once, in the reporting period in which it first meets the criteria for reporting. After the impairment / disorder is reported once post-infusion, it should never be reported again. ; If pancreatitis was reported as Developed or Persisted in a prior reporting period (regardless of it recurred), not present in the current reporting period or unknown if present, select Not present.
4/24/2026	3504: Organ Function / Late Effects	Add	Clarified intent of Q64 – 65 and when to report ‘not present’: Congestive heart failure (CHF) is the inability of the heart to supply oxygenated blood to meet the body’s needs, with an ejection fraction < 40%. Indicate if congestive heart failure was present in the current reporting period. intent of this question is only to capture the first occurrence of the impairment / disorder in the recipient’s post-infusion course. The impairment / disorder should be reported once, in the reporting period in which it first meets the criteria for reporting. After the impairment / disorder is reported once post-infusion, it should never be reported again. ; If congestive heart failure was reported as Developed or Persisted in a prior reporting period (regardless of it recurred), not present in the current reporting period, or unknown if present, select Not present.
4/24/2026	3504: Organ Function / Late Effects	Add	Clarified intent of Q21 and when to report ‘not present’: Cirrhosis is a degenerative disease in which fibrous tissue forms and the lobes become filled with fat. Cirrhosis may be diagnosed using a liver biopsy, but clinical symptoms (enlarged liver), blood tests, laparoscopy, or radiology imaging are often used to determine the diagnosis of cirrhosis when a liver biopsy is not necessary. Indicate if cirrhosis was present in the current reporting period. The intent of this question is only to capture the first occurrence of the impairment / disorder in the recipient’s post-infusion course. The impairment / disorder should be reported once, in the reporting period in which it first meets the criteria for reporting. After the impairment / disorder is reported once post-infusion, it should never be reported again. ; If cirrhosis was reported as Developed or Persisted in a prior reporting period (regardless of it recurred), not present in the current reporting period, or unknown if present, select Not present.
4/24/2026	3504: Organ Function / Late Effects	Add	Table 1. When the Organ Function / Late Effects (3504) Comes Due for Stand Alone Infusions and Table 2. When the Organ Function / Late Effects (3504) Comes Due for Combined Follow-Up added to the introduction page. The previous Table 1. Organ Impairments / Disorders Enabled Based on Infusion Type is now Table 3. Organ Impairments / Disorders Enabled Based on Infusion Type
3/27/2026	3504: Organ Function / Late Effects	Add	Version 1 Organ Function / Late Effects (3504) section of the Forms Instructions Manual released. Version 1 corresponds to revision 1 of the Form 3504.

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