Q43-98: Therapy

Treatment for VOD/SOS is generally intended to normalize flow through the hepatic vessels by resolving the central venous and sinusoidal obstruction and preventing fibrosis. Supportive therapies such as hypertransfusions may also be started to improve renal and pulmonary function. Do not report these supportive therapies in this section of the form. Report any treatment initiated as a result of the diagnosis of VOD/SOS.

!Drugs given for Liver Prophylaxis
For prophylaxis medications continued after the date of VOD/SOS diagnosis, only report the treatment if the dose was increased to induce a therapeutic effect.

Question 43: Was therapy given?

Report “yes,” if any treatment was given for the diagnosis of VOD/SOS. If “yes,” specify any treatment given during the reporting period in questions 44-98. If “no,” continue with question 99.

Question 44: Defibrotide

Report “yes,” if defibrotide was given for VOD/SOS during the reporting period. If “yes,” continue with question 45. If “no,” continue with question 66.

Question 45: Planned total daily dose

Indicate the planned total daily dose of defibrotide. The most common dose of Defibrotide used in the treatment of VOD/SOS is 6.25 mg/kg IV every 6 hours. The planned total daily dose would be 25 mg/kg. The planned dose will be documented prior to the initiation of therapy, usually in the orders. The actual dose may be adjusted based on reactions or complications experienced after treatment is started. Do not report dose adjustments made after treatment is started.

Question 46: Date started:

Report the date the first dose of defibrotide was administered. If defibrotide was continued from a prior reporting period, leave this field blank and override the error in FormsNet using the code “Verified Correct.”

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

Question 47-48: Was this therapy still being given at the date of last contact (defibrotide)?

Indicate whether the recipient is still taking defibrotide on the date of contact. If “no,” report the date the last dose of defibrotide was administered.

If the recipient has died prior to the discontinuation of defibrotide used to treat VOD/SOS, select “yes”.

Question 49: Recipient weight: (at initiation of therapy)

Report the recipient’s weight on the first date defibrotide was administered. If the recipient’s weight was not measured at the initiation of defibrotide, report the weight used to determine the planned total daily dose.

Question 50-53: Lab results on therapy start date

For each laboratory study, report “known” if testing was performed on the date defibrotide was started followed by the result. Report “unknown” if testing was not performed or the results are not available.

Question 54-55: Specify the oxygen requirements (at initiation of therapy)

Indicate the highest level of oxygen support on the date defibrotide was started. If “Other oxygen requirement” is being reported, continue with question 55 and specify the type of support required.

Question 56-57: Specify the reason therapy stopped (defibrotide)

Indicate the reason defibrotide was stopped during the reporting period using one of the following options:

!Death: Currently, death appears as a reason for stopping therapy on the form. Centers should not use this option choice. Rather, if the recipient has died prior to the discontinuation of defibrotide, centers should report “yes” for question 47. This will cause questions 56-57 to be disabled, preventing the center from answering these questions.

• Complete resolution: The following guidelines are provided to assist data managers in determining whether the symptoms of VOD/SOS have completely resolved:
  • Bilirubin < 2.0 mg/dL (34 µmol/L)
  • Serum creatinine <1.5 times the upper limit of normal OR less than the upper limit of normal based on patient’s age.
  • Increase of greater than 80% in creatinine clearance/GFR compared to values at time of diagnosis and not currently on dialysis.
  • Greater than 90% oxygen saturation on room air AND no supplemental oxygen or ventilator requirements.

If a complete resolution of symptoms is documented in the progress notes, but the above guidelines have not been met, data managers should obtain documentation from the appropriate care provider clarifying whether any persistent symptoms are being attributed to VOD/SOS or another cause.

• Completed prescribed course / end of treatment protocol: The recipient has completed their full course of treatment without complete resolution of symptoms.
• Discharged from hospital: The recipient ended treatment early due so they could be discharged. Use this option for recipients who discontinue treatment as part of their transition to palliative care.
  

Do not use this option for recipients who have demonstrated a complete resolution of symptoms following treatment or recipients who completed their entire prescribed course of treatment prior to discharge.

• Side effect(s): Treatment was completely stopped due to complications which are believed to be associated with that drug. Specify the side effects in questions 58-65.
• Other: Use this option choice for any reason not included above. Centers must specify the reason in question 57 when reporting “other.”
  

Question 58-63: Bleeding

Indicate whether bleeding occurred as a side effect of treatment. If bleeding was a side effect, report the sites at which bleeding occurred in questions 59-63. If bleeding was not a side effect, continue with question 64.

This question should only be completed if the center has reported treatment was stopped due to side effects in question 56.

Question 64-65: Other side effect

Report “yes” if the recipient experienced any side effects of treatment other than bleeding. Specify other side effects in question 65. If no other side effects occurred, continue with question 66.

This question should only be completed if the center has reported treatment was stopped due to side effects in question 56.

Question 66-98: Additional treatment for VOD/SOS

These questions are intended to capture any other treatments initiated to manage or resolve complications associated with VOD/SOS.

For any drugs given as treatment for VOD/SOS, report the first date treatment was given during the reporting period and whether treatment is still being given on the date of contact. If treatment was stopped prior to the date of contact, report the last date treatment was given. For more information regarding reporting partial or unknown dates, see General Instructions, General Guidelines for Completing Forms.

If a recipient received treatment for VOD/SOS and it was not discontinued prior to their date of death, report “yes” for question 68 “Was this therapy still being given at the date of last contact?”

If the recipient received a therapy other than the drugs listed, report “yes” for “other therapy” and specify the treatment(s) in question 95.

Section Updates:

Question Number	Date of Change	Add/Remove/Modify	Description	Reasoning (If applicable)
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