This form is a Common Form and can be found in the Common Forms section. This form comes due if the Study arm = Abatacept intervention arm on Enrollment and Randomization form.
Refer to ACCEL-001 ISA for administration details.
Timepoint:
The lab form comes pre-populated in the table with Timepoints Day 5, Day 14, Day 28 and Day 56. These cannot be edited.
Was Abatacept administered per protocol:
Report whether Abatacept was administered at each timepoint per protocol as Yes or No.
Per ACCEL-001 ISA, Abatacept will be given at a dose of 10 mg/kg with a maximum of 1000 mg. The first 3 doses (Days 5, 14, and 28) will be based on a dose calculation weight which is calculated within one week of the Day -1 dose. However, for the first 3 doses (Days 5, 14, 28), if a weight gain or loss of > 10% compared to the original dose calculation weight is recorded in the most recent weight prior to infusion, a new dose calculation weight should be used. The abatacept doses given on Days +5, +14 shall be given on the exact date (no dosing window). The abatacept dose given on Day +28 ± 1 day includes a dosing window and Day +56 ± 3 days includes a dosing window.
Date Abatacept administered:
Report the Date Abatacept was administered at each timepoint in DD/MMM/YYYY format.
Start of infusion:
Report the start time of Abatacept infusion. Time should be entered using the 24 hour clock.
End of infusion:
Report the end time of Abatacept infusion. Time should be entered using the 24 hour clock.
Dose Administered:
Report the dose administered of this Abatacept in mg in “XX.XX” format. This format allows for up to two digits prior to the decimal and up to two digits after the decimal.
Dose adjusted due to weight change?:
Report if the dose was adjusted due to weight change as “Yes” or “No.” The first 3 doses (Days 5, 14, and 28) will be based on a dose calculation weight which is calculated within one week of the Day -1 dose. However, for the first 3 doses (Days 5, 14, 28), if a weight gain or loss of > 10% compared to the original dose calculation weight is recorded in the most recent weight prior to infusion, a new dose calculation weight should be used.
Subject’s weight at time of dosing:
Report the subject’s weight (in kg or lbs) at time of dosing in XXX.X format. This format allows up to three digits prior to the decimal and up to one digit after the decimal.
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