The purpose of this section is to capture any impairments or disorders present during the current reporting period, regardless of treatment or intervention, unless otherwise specified. Review each impairment or disorder description to determine whether treatment or intervention is required for reporting the condition.
Questions 19 – 20: Specify therapy used to prevent liver toxicity (check all that apply)
Liver toxicities 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 preparative regimen and may be continued well after the infusion.
Select all therapy the recipient received intended to prevent liver toxicity during the reporting period, including therapy given during the preparative regimen. Report only agents given to prevent liver toxicities, not those given to treat a diagnosed liver injury or toxicity.
If Other therapy is selected, specify the therapy.
If therapy to prevent liver toxicity was not given in the reporting period, select No therapy used.
Questions 21 – 22: Was cirrhosis 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.
Report Developed in the following scenarios:
- This is the first time the recipient was diagnosed with cirrhosis in the reporting period.
If cirrhosis 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.
Do not report a recurrence of cirrhosis. Only the first occurrence is captured.
For more information regarding reporting partial or unknown dates, see General Instructions, General Guidelines for Completing Forms.
Report Persisted in the following scenarios:
- For transplant, if cirrhosis was diagnosed pre-infusion and persisted into the Day 100 reporting period.
- For cellular therapy, if cirrhosis 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.
When this is diagnosed post-infusion, do not report cirrhosis if it continued from a previous reporting period into the current reporting period, even if it was present.
If cirrhosis Persisted, report the onset date. For HCT, this date will be a date prior to the infusion (i.e., prior to Day 0). For cellular therapy, this date will either be a date prior to the infusion (i.e., prior to Day 0), or from the Day 100, or six-month reporting period, depending on when cirrhosis was first diagnosed.
For more information regarding reporting partial or unknown dates, see General Instructions, General Guidelines for Completing Forms.
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.
Questions 23 – 24: Was a non-infectious liver toxicity present? (excluding GVHD)
Indicate if a non-infectious liver toxicity, excluding GVHD, was preset in the current reporting period. See below for a list of non-infectious liver toxicities.
Report Developed in the following scenarios:
- This is the first time the recipient was diagnosed with non-infectious liver toxicity in the reporting period.
- Non-infectious liver toxicity resolved in a prior reporting period and then recurred in the current reporting period.
If non-infectious liver toxicity 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:
- Non-infectious liver toxicity was diagnosed pre-infusion and persisted into the Day 100 reporting period.
- Non-infectious liver toxicity was diagnosed (or persisted) in the prior reporting period and persisted into the current reporting period.
If non-infectious liver toxicity was not present in the current reporting period or unknown if present, select Not present.
Questions 25 – 26: Select the non-infectious liver toxicity / etiology
Specify the non-infectious liver toxicity / etiology, excluding GVHD.
- 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.
- Medication toxicity: If the liver abnormality (i.e., abnormal LFT values) is associated with drug initiation, abnormalities improve with cessation, and / or there are no other causes for the change.
- Other etiology: Liver toxicity other than VOD / SOS or cirrhosis. Do not include hepatic infections or GVHD.
- Unknown etiology: If there is a liver toxicity; however, 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 of the reporting period.
Questions 27 – 28: Did non-infectious liver toxicity resolve?
Indicate if the non-infectious liver toxicity resolved during the reporting period. If Yes, report the resolution date. The resolution date is the date when the notes specify the condition as resolved and / or medications to treat the condition were completed.
For more information regarding reporting partial or unknown dates, see General Instructions, General Guidelines for Completing Forms.
Section Updates:
| Question Number | Date of Change | Add/Remove/Modify | Description | Reasoning (If applicable) |
|---|---|---|---|---|
| Q21 | 4/24/2026 | Add | Clarified intent of question 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. | Added for clarification |
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