Links within section:
Pulmonary Function
Liver Toxicity Prophylaxis
Liver Function
Thrombotic Microangiopathy
Other Organ Impairment / Disorder

Pulmonary Function

Question 441-485: Indicate any non-infectious pulmonary abnormalities diagnosed since the date of the last report.

Report any non-infectious pulmonary abnormalities diagnosed since the date of the last report. See below for a description of reportable abnormalities as well as common methods of assessment.

Non-Infectious Pulmonary Abnormalities:

Interstitial pneumonitis / Acute respiratory distress syndrome (IPn/ARDS): IPn refers to inflammation of the alveolar walls. Acute respiratory distress syndrome typically refers to fluid build-up within the alveoli. In either case, gas exchange is impaired resulting in oxygen deprivation. Both conditions can result from infectious or non-infectious causes. Only report IPn / ARDS resulting from non-infectious causes in questions 441-485.

Idiopathic pneumonia syndrome (IPS): all non-infectious lung injuries that occur early after HCT (within 100-120 days) including: peri-engraftment respiratory distress syndrome (PERDS), interstitial pneumonitis without a pathogen, radiation / drug-induced lung injury, or transfusion-associated lung injury (TRALI).

Bronchiolitis obliterans (BO): an airway obstruction as a result of inflammation of the bronchioles. This complication typically occurs late after HCT. It is often a manifestation of chronic GVHD. If bronchiolitis obliterans is a result of chronic GVHD, confirm that bronchiolitis obliterans was also reported in the chronic GVHD section of this form (question 311).

Cryptogenic organizing pneumonia (COP) / Bronchiolitis obliterans with organizing pneumonia (BOOP): an idiopathic form of pneumonia which affects different parts of the lungs including the bronchioles and alveoli. This complication typically occurs late after HCT.

Diffuse alveolar hemorrhage (DAH): bleeding into the alveolar space typically resulting from an injury to the pulmonary blood vessels.

Other non-infectious abnormalities: any other non-infectious pulmonary abnormalities not already captured in the above categories. Do not report pleural effusions here.

Diagnostic Methods:

Bronchoalveolar lavage (BAL): a procedure in which a bronchoscope is guided into the lower respiratory system. Fluid is emitted from the bronchoscope and then collected for further examination.

Transbronchial biopsy: a procedure in which forceps on the end of the bronchoscope are used to collect lung tissue samples for further examination.

Open / thorascopic lung biopsy: An open lung biopsy is a procedure in which an incision is made between the ribs to collect a sample of lung tissue for further examination. A thorascopic lung biopsy is a procedure in which an incision is made to the chest and an endoscope is used to collect samples of lung tissue.

Autopsy: a post-mortem procedure used to determine the cause of death and to evaluate other disease present at the time of death.

Other: Specify “other diagnostic test” for IPn / ARDs or IPS in question 449, excluding radiographic assessment.

For any reported abnormalities, report the date of diagnosis and the diagnostic tests performed. 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.

Documentation of diagnostic tests may be attached to the form. For further instructions on how to attach documents in FormsNet3, refer to the training guide.

Question 486-487: Did the recipient receive endotracheal intubation or mechanical ventilation post-HCT?

Endotracheal intubation or mechanical ventilation may be used post-HCT for respiratory failure or for airway protection from severe mucositis.

Invasive positive pressure ventilation is delivered via an endotracheal tube. Do not include non-invasive positive pressure ventilation that is delivered through an alternate interface (e.g., facemask).

Indicate whether the recipient received endotracheal intubation or mechanical ventilation (invasive positive pressure ventilation) post-HCT. If “yes,” report the date when endotracheal intubation or mechanical ventilation was started in question 487. If the recipient was intubated multiple times within the reporting period, please report the first date of intubation. If “no,” continue with question 490. Please report “no” if the patient received endotracheal intubation or mechanical ventilation during surgery.

For more information regarding reporting partial or unknown dates, see General Instructions, General Guidelines for Completing Forms.

Question 488-489: Was the recipient successfully extubated?

Indicate if the recipient was successfully extubated during the reporting period. If “yes,” report the date of extubation in question 489. If the recipient was extubated multiple times within the reporting period, please report the last date of extubation. If “no,” continue with question 490.

For more information regarding reporting partial or unknown dates, see General Instructions, General Guidelines for Completing Forms.

Liver Toxicity Prophylaxis

Question 490: Was specific therapy used to prevent liver toxicity?

Liver toxicities in transplant patients may be related to drugs / treatments, infection, GVHD, iron overload, cirrhosis, or sinusoidal obstructive syndrome (SOS) / veno-occlusive disease (VOD). Agents such as ursodiol may be given as prophylaxis against one or more of these transplant-related liver injuries. Agents given to prevent liver toxicity will generally be started prior to or during the conditioning regimen, and may be continued well after transplant.

Indicate whether the recipient received any therapy intended to prevent liver toxicity during the reporting period, including therapy given during the conditioning regimen. Report only agents given to prevent liver toxicities, not those given to treat a diagnosed liver injury or toxicity. If liver toxicity prophylaxis was given, report “yes” and complete with questions 491-496. If liver toxicity prophylaxis was not given during the reporting period, report “no” and continue with question 497.

Question 491-496: Specify therapy (Defibrotide, N-acetylcysteine, tissue plasminogen activator (TPA), Ursodiol, Other)

Report all agents given during the reporting period to prevent liver toxicity, including therapy given during the conditioning regimen. Only report agents given to prevent liver toxicities, not those given to treat a diagnosed liver injury or toxicity. If “other” therapy is reported in question 495, specify agent in question 496.

Liver Function

Question 497: Did the recipient develop non-infectious liver toxicity (excluding GVHD) since the date of last report?

Indicate whether the recipient developed a non-infectious liver toxicity during the reporting period. Include and toxicities which developed between the start of the preparative regimen and the date of last contact (question 1) when completing the 100 day follow-up form. Do not report liver complications due to GVHD in this section. If “yes,” continue with question 498. If “no,” continue with question 507.

Question 498-506: Specify the non-infectious liver toxicity etiology (veno-occlusive disease (VOD) / sinusoidal obstruction syndrome (SOS), cirrhosis, other, and unknown etiology)

Report the etiology of the non-infectious liver toxicity that the recipient developed since the date of the last report in questions 498-506.

Veno-occlusive disease (VOD) / sinusoidal obstruction syndrome (SOS): occurs following injury to the hepatic venous endothelium, resulting in hepatic venous outflow obstruction due to occlusion of the hepatic venules and sinusoids. This typically results in a distinctive triad of clinical signs including hepatomegaly with right upper quadrant tenderness, third space fluid retention (e.g., ascites), and jaundice with a cholestatic picture. For more information on VOD / SOS including diagnostic criteria, refer to the VOD / SOS section of the Forms Instructions Manual.

Question 498-499: Did veno-occlusive disease (VOD) / sinusoidal obstruction syndrome (SOD) develop since the date of last report?

Indicate whether VOD / SOS was diagnosed during the reporting period. If “yes,” report the date of diagnosis in question 499. If VOD / SOS persisted from the prior reporting period, indicate “no” and continue with question 500.

For more information regarding reporting partial or unknown dates, see General Instructions, General Guidelines for Completing Forms.

Question 500-501: Cirrhosis

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 whether cirrhosis was diagnosed during the reporting period. If “yes,” report the date of diagnosis in question 501. If cirrhosis persisted from a prior reporting period, indicate “no” and continue with question 502.

For more information regarding reporting partial or unknown dates, see General Instructions, General Guidelines for Completing Forms.

Question 502-504: Other etiology

Report liver complications not listed above. Do not include hepatic infections or GVHD. Report infections in the Infection section (questions 428-440); and GVHD in the Acute GVHD section (questions 157-233) and / or in the Chronic GVHD section (questions 234-406).

If reporting “yes” for “other etiology,” specify the documented etiology in question 503 and report the date of diagnosis in question 504. If reporting “no,” continue with question 505.

For more information regarding reporting partial or unknown dates, see General Instructions, General Guidelines for Completing Forms.

Question 505: Unknown etiology

Indicate “unknown” if there is no information about the etiology of the non-infectious liver toxicity. This option should be used sparingly and only when no judgment can be made about the etiology in the reporting period.

Thrombotic Microangiopathy (TMA)

Thrombotic microangiopathy (TMA) is a multifactorial condition where intravascular platelet activation, formation of thrombi, and microangiopathic hemolytic anemia occur due to generalized endothelial dysfunction. Organ injury, specifically the kidney, may occur as a result of these processes.1 Characteristics of thrombotic microangiopathy includes microangiopathic hemolysis, thrombocytopenia (< 50 ×109/L), neurological changes, and pulmonary dysfunction: Other laboratory features include:

  • LDH greater than the center-specific upper limit of normal
  • Serum creatinine > 2 mg/dL or >50% rise over baseline
  • Bilirubin greater than twice the center-specific upper limit of normal

1 Jodele, S., M. Davies, and B.L. Laskin. “Diagnostic and Risk Criteria for HSCT-associated Thrombotic Microangiopathy: A Study in Children and Young Adults.” Blood 124.4 (2014): 645-53. Web.

Question 506: Did the recipient develop post-transplant thrombotic microangiopathy (TMA) (include microangiopathy, thrombotic thrombocytopenia purpura (TTP), hemolytic uremic syndrome (HUS)), or similar syndrome since the date of last report?

Microangiopathy: Disease of the capillaries where the capillaries bleed and slow the flow of blood due to thickening and weakening of capillary walls.

Thrombotic thrombocytopenia (TTP): Blood disorder where blood clots form in the small blood vessels of the body.

Hemolytic uremic syndrome (HUS): Abnormal destruction of red blood cells which block the kidneys resulting in kidney failure. May be caused by Escherichia coli, other infections, and medications.

Indicate whether the recipient developed post-transplant TMA or a similar syndrome since the date of last report. If “yes,” continue with question 507. If “no,” continue with question 527.

Question 507: Date of diagnosis:

Report the clinical diagnosis date of post-transplant TMA or a similar syndrome, including microangiopathy, TTP, and HUS. For more information regarding reporting partial or unknown dates, see General Instructions, General Guidelines for Completing Forms.

Question 508-512: Specify signs and symptoms:

For each option listed, indicate whether the recipient had any signs or symptoms due to post-transplant TMA or a similar syndrome during the reporting period.

Question 513-517: Was TMA evaluated by biopsy?

Indicate whether TMA was evaluated by a biopsy. If “yes,” report if the results were “positive,” “suggestive,” “negative,” “inconclusive / equivocal,” or “not done” for each option listed. If “other site” is reported, specify the biopsy site in question 516.

Indicate whether documentation was submitted to CIBMTR in question 517. For further instructions on how to attach documents in FormsNet3, refer to the training guide.

Question 518-524: Was therapy given for TMA?

Indicate whether the recipient received any therapy intended to treat TMA during the reporting period. Report only agents given to treat a diagnosis of TMA. If “yes,” report all therapy given during the reporting period in questions 519-524. If “no,” continue with question 525.

Question 525: Did the TMA resolve? (Normalization of renal function, LDH, and resolution or improvement in renal and / or neurologic dysfunction)

Indicate whether TMA resolved. If “yes,” report the first date the recipient the recipient met the following criteria:

  • Normalization of renal function (per institutional guidelines);
  • Normalization of LDH (per institutional guidelines);
  • Resolution / improvement of renal and neurologic dysfunction.

If TMA did not resolve during the reporting period, skip question 526 and continue with question 527.

Other Organ Impairment / Disorder

Question 527: Has the recipient developed any other clinically significant organ impairment or disorder since the date of last report?

The intent of this question is to identify serious conditions or impairments occurring after transplant. For the purposes of this manual, the term “clinically significant” refers to conditions requiring treatment or intervention. Additional guidelines for commonly reported organ impairments and disorders are included below. Do not report complications that are expected for most transplant recipients and do not require treatment (i.e., minor complications resolving without intervention).

Indicate whether the recipient developed any other clinically significant organ impairment or disorder during the reporting period. If this form is being completed for the 100 day reporting period, include any clinically significant impairments or disorders diagnosed between the start of the preparative regimen and the date of contact (question 1). If “yes,” complete questions 528-610. If “no,” continue with question 611.

Do not report any impairments / disorders which have persisted since the last report. If this form is being completed for the 100 day reporting period, do no report conditions which have persisted since before the start of the preparative regimen.

Questions 528-610: Specify impairment / disorder:

Indicate whether any of the organ impairments or disorders listed were diagnosed during the reporting period. If the recipient developed an impairment during the reporting period, report “yes,” enter the date of diagnosis, and answer any additional questions pertaining to the impairment / disorder. 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.

Renal

Acute renal failure requiring dialysis: report whether dialysis was ordered or recommended for renal failure. Also report whether the recipient received the treatment. Symptoms of renal failure include dehydration, nausea, blood in the urine, and / or swelling of extremities.

Chronic kidney disease / renal impairment: report whether there was chronic kidney disease or renal impairment (persistent decrease in glomerular filtration to <60 mL/min.1.73m2). Also report whether the recipient received treatment.

Cardiac

Arrhythmia: report whether the recipient developed an arrhythmia, including atrial fibrillation or flutter, sick sinus syndrome, and ventricular arrhythmia. Specify the arrhythmia. If “other arrhythmia” is reported, specify in question 542.

Congestive heart failure (CHF): inability of the heart to supply oxygenated blood to meet the body’s needs. Ejection fraction < 40%.

Coronary artery disease: damage or disease in the major blood vessels of the heart. Also called CAD, atherosclerotic heart disease.

Myocardial infarction (MI): an obstruction in the coronary artery resulting in damage / necrosis to the cardiac muscle.

Hypertension (HTN) requiring therapy: report whether treatment was given for high blood pressure.

Vascular

Deep vein thrombosis (DVT) / Pulmonary embolism (PE): development of a blood clot in a deep vein or development of a blood clot in the arteries of the lung.

Neurological

CNS hemorrhage: bleeding within the central nervous system.

Encephalopathy: damage or disease of the brain. Symptoms of encephalopathy include memory loss, personality changes, and declining ability to concentrate and reason.

Neuropathy: nerve damage, usually in hands and feet, which causes pain, weakness, and numbness.

Seizures: sudden, involuntary muscle contractions due to the hyperexcitation of neurons.

Stroke: loss of brain function due to a disturbance in the blood supply to the brain.

Endocrine

Diabetes / hyperglycemia: high blood glucose levels. Diabetes / hyperglycemia should only be reported if insulin and / or oral medication is required for treatment. Diabetes / hyperglycemia controlled through diet and exercise should not be reported.

Growth hormone deficiency / short stature: a condition in which the body does not produce enough growth hormone / a reduced overall rate of growth.

Hypothyroidism requiring replacement therapy: decreased activity of the thyroid gland. Diagnosis of hypothyroidism includes high levels of thyroid-stimulating hormone (TSH). Symptoms of hypothyroidism include fatigue, depression, weakness, weight gain, musculoskeletal pain, decreased taste, hoarseness, and / or puffy face.

Pancreatitis: inflammation of the pancreas.

Genitourinary

Gonadal dysfunction requiring hormone replacement (testosterone or estrogen): Females may experience early symptoms of menopause including amenorrhea. Males may experience decreased spermatogenesis. Low levels of follicle stimulating hormone (FSH), luteinizing hormone (LH), and / or testosterone may require hormone replacement therapy.

Hemorrhagic cystitis / hematuria requiring medical intervention (catheterization of bladder, extra transfusions, urology consult): characterized by bleeding and inflammation of the bladder wall. Hemorrhagic cystitis may result from systemic chemotherapy or radiation therapy and / or some viral infections (e.g., BK virus). Report cases with macroscopic (visible to the naked eye) or gross hematuria (WHO Grade III and IV hemorrhagic cystitis). If the etiology is infectious, also report in the Infection section (questions 291-295). Examples of medical intervention include catheterization of bladder, extra transfusions, or a urology consult.

Musculoskeletal

Avascular necrosis: localized tissue death due to inadequate oxygen to the cells. Also known as coagulation necrosis or ischemic necrosis.

Osteonecrosis of the jaw: bones of the jaw weaken and die due to potent antiresorptive medications such as bisphosphonates or RANKL inhibitors, infection, steroid use, and treatment of cancer, including radiation.

Osteoporosis: bones become weak and brittle due to losing bone mass faster than it is created from aging.

Osteoporotic fracture: fractures due to low bone mineral density.

Psychiatric

Depression requiring therapy: mood disorder resulting in persistent feeling of sadness and loss of interest. Common treatments include antidepressant, anxiolytic, and antipsychotic medications. Common names include Amitriptyline, Bupropion (Wellbutrin), Buspirone, and Abilify.

Anxiety requiring therapy: disorder characterized by feelings of worry, anxiety, or fear which are strong enough to interfere with daily activities. Common medications include Duloxetine (Cymbalta), Diazepam (Valium), Buspirone, Pregabalin (Lyrica).

Post-traumatic stress disorder (PTSD) requiring therapy: condition triggered by seeing or experiencing a traumatic event.

Other

Cataracts: loss of transparency in the lens of the eye.

Hyperlipidemia requiring therapy (high total cholesterol, high LDL cholesterol, and / or high triglyceride levels): high levels of lipids (fat particles) in blood. Common drugs includes Atorvastatin (Lipitor), Simvastatin (Zocor), Ezetimibe (Zetia), and Simvastatin (Vytorin).

Iron overload requiring therapy: condition characterized by having too much iron in the body. Therapy includes phlebotomy and iron chelation. Indicate which therapy is required. If “other therapy” is required, specify if in question 605.

Iron overload cannot be answered on the day 100 form. Iron overload questions will be answered for all subsequent reporting periods.

Mucositis requiring therapy: inflammation and ulceration of mucous membranes that line the digestive tract, usually due to chemotherapy and radiotherapy. Specify the grade as “0 (none),” “I (mild) – oral soreness, erythema,” “II (moderate) – oral erythema, ulcers, solid diet tolerated,” “III (severe) – oral ulcers, liquid diet only,” or” IV (life-threatening – oral ulcers, oral alimentation impossible.” Do not report mucositis which did not require treatment or intervention during the reporting period.

Mucositis can only be answered on the day 100 form. Mucositis questions will be skipped for all subsequent reporting periods.

Other impairment or disorder: use this category to report any clinically significant impairment(s) / disorder(s) not listed on the form. Specify the other impairment / disorder in question 610.

Do not report complications that have been reported elsewhere on the form.

Question 611-613: Has the recipient received a solid organ transplant since the date of last report?

Indicate whether the recipient received a solid organ transplant since the date of the last report. If “yes,” specify the organ transplanted in question 612. If “other organ” is reported, specify organ in question 613. If the recipient did not receive a solid organ transplant during the reporting period, report “no” for question 611 and continue with question 616.

Solid organ transplant questions cannot be answered on the day 100 or 6 month forms. These questions will be answered for all subsequent reporting periods.

Question 614: Date of transplant:

If the recipient received a solid organ transplant during the reporting period, report the date of the solid organ transplant.

For more information regarding reporting partial or unknown dates, see General Instructions, General Guidelines for Completing Forms .

Question 615: Specify solid organ donor type:

Specify if the solid organ donor was a “living related donor,” “living unrelated donor,” or a “cadaveric donor.

Last modified: Jul 07, 2020

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