Q54 – 61 Disease Modifying Therapies

Question 54: Were disease modifying therapies given? (excludes blood transfusions)

Indicate if the recipient received disease modifying therapies (review the question below for a list of common disease modifying therapies) during the current reporting period, excluding blood transfusion(s).

If the recipient did not receive disease modifying therapies or if no information is available to determine if the recipient received disease modifying therapies, select No or Unknown, respectively and submit the form.

*Reporting Multiple Disease Modifying Therapies
FormsNet3^SM application: Complete questions 55 – 61 for each disease modifying therapy administered by adding an additional instance in FormsNet3^SM application.
Paper form submission: Copy questions 55 – 61 and complete for each disease modifying therapy administered.

*Same Therapy Restarted
If the same therapy was started and stopped multiple times during the current reporting period, only one instance needs to be reported. In this case, report the therapy start date as the date therapy first began in the reporting period.

Questions 55 – 56: Specify the disease modifying therapy (check all that apply)

Select the disease modifying therapy administered as part of the line of therapy being reported.

• Leriglitazone: a novel selective peroxisome proliferator-activated receptor gamma agonist.

If the recipient received a therapy which is not listed, select Other and specify the treatment. Report the generic name of the agent, not the brand name.

Question 57: Was the date therapy started previously reported?

Specify if the therapy start date was previously reported. If the therapy was started in a prior reporting period and continued into the current reporting period, select Yes, and continue with Date Therapy Started.

The Yes option is not applicable for the Day 100 reporting period.

Questions 58 – 59: Date therapy started

Indicate if the therapy start date is known. If Known, report the first date (YYYY-MM-DD) the recipient began this line of therapy.

If the exact date is not known report an estimated date and check the Date estimated box. Refer to General Instructions, General Guidelines for Completing Forms for information about reporting estimated dates.

Questions 60 – 61: Date therapy stopped

Indicate if the stop date is known. If the therapy stop date is Known, report the date (YYYY-MM-DD) when the therapy end. If the therapy is being given in cycles, report the end date as the date when the recipient started the last cycle for this line of therapy. Otherwise, report the final administration date for the therapy being reported.

If the exact date is not known report an estimated date and check the Date estimated box. Refer to General Instructions, General Guidelines for Completing Forms for information about reporting estimated dates.

Report Not applicable if the recipient is still receiving therapy on the contact date.

Section Updates:

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