This form is a Common Form and can be found in the Common Forms section. This form comes due if the Study arm = Ruxolitinib intervention arm on Enrollment and Randomization form.
Refer to ACCEL-002 ISA for administration details.
Was ruxolitinib administered in accordance with the protocol:
Report if ruxolitinib was administered in accordance with the protocol as “Yes” or “No.”
Specify reason ruxolitinib was not administered in accordance with the protocol:
This field will only appear in EDC if “Was ruxolitinib administered in accordance with the protocol” is answered No. Please report the reason ruxolitinib was not administered per protocol in this free textbox (up to 200 characters).
Describe how ruxolitinib dosing and/or administration differed from the protocol recommended dosing and administration:
This field will only appear in EDC if “Was ruxolitinib administered in accordance with the protocol” is answered No. Please report the agent, dose, route, and days administered in this free textbox (up to 200 characters).
Ruxolitinib Dose Administration
Report a new section to capture start and stop dates at each dose level
Start date:
Report the start date of administration at each daily dose level in DD/MMM/YYYY format.
Stop date:
Report the end date this administration at each daily dose level in DD/MMM/YYYY format.
Total daily dose:
Report the total daily dose of Ruxolitinib in mg/kg in “XXXX.XX” format. This is not the sum of dosing across all dates at this dosing level. This format allows for up to four digits prior to the decimal and up to two digits after the decimal.
Reason dose adjusted:
Select the reason dose was adjusted for each dose level. For reporting the initial dose, select “N/A – First Dose).
Specify Other:
This field will only appear in EDC if “Reason dose adjusted:” is answered “Other.” Please report the other reason in this free textbox (up to 200 characters).
Describe adverse effect:
This field will only appear in EDC if “Reason dose adjusted:” is answered “Adverse event.” Please describe the adverse event in this free textbox (up to 200 characters).
Link to AE:
This field will only appear in EDC if “Reason dose adjusted:” is answered “Adverse event.”
To add a link to an Adverse Event form, you must first have entered the AE form to report the event. Next, on this form click +Select under the Link to AE field. In the pop-up window, select the Adverse Event to link by clicking on the checkbox to the left of the Reference # then click Save.
CCG v1.0 | CRF v1.3
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