To access follow-up visit CRFs, click on the Enter Date box and enter the date of the study visit. Click Save. If the date entered is a future date, a query will appear in the EDC.
Neutrophil Recovery
ANC recovery is defined as an absolute neutrophil count (ANC) of ≥ 0.5 × 109/L (500/mm3) for three consecutive laboratory values obtained on different days. Date of ANC recovery is the date of the first of three consecutive laboratory values where the ANC is ≥ 0.5 × 109/L. At some institutions, the laboratory reports display the ANC value once there are sufficient white blood cells to perform a differential count. At other institutions, the laboratory reports do not display the ANC, and it must be calculated from the white blood cell count (WBC) and the percent of segmented and band neutrophils (if the differential was performed on a machine, the percent neutrophils will include both segmented and band neutrophils). If the laboratory report displays an automated ANC value of exactly 0.5, the actual ANC value should be calculated from the manual differential if available. The calculated value from the manual differential will determine ANC recovery. If the institution’s laboratory reports do not display the ANC value, use the following calculation to determine the ANC:
Example 1: Calculating Absolute Neutrophil Count (ANC)
1. Traditionally, the definition of ANC recovery required selecting the first date of three consecutive days in which the subject’s ANC was ≥ 0.5×109/L (500/mm3). For various reasons it may not be possible to obtain daily laboratory values. Under those circumstances, report ANC recovery based upon three consecutive laboratory values (drawn more than a day apart) as long as the ANC remains ≥ 0.5×109/L (500/mm3).
Tracking the date of ANC recovery may not always be straightforward. In some cases the ANC may fluctuate for a period of time before the subject fully recovers. In other cases the ANC may remain above 0.5 × 109/ L for several days immediately post-HCT and then fall below 0.5 ×109/L. Do not begin counting ANC values of ≥ 0.5 × 109/L towards recovery until the ANC has dropped to the lowest level (nadir) post-HCT. If the subject was transplanted using a reduced intensity (RIC) regimen, the subject’s ANC may never drop below 0.5 × 109/L. If this is the case, an ANC recovery date will not be reported, and the “never below” option should be chosen. However, if the subject’s ANC drops below 0.5×109/L for even one day, this should be considered the nadir and “never below” should not be chosen. See the following example for more information regarding tracking the date of ANC recovery.
Example 2: Tracking ANC Recovery
Was there evidence of hematopoietic recovery:
Indicate if there was evidence of hematopoietic recovery by selecting the most appropriate response from the following options:
- Yes (ANC greater than or equal to 0.5 × 109/L (500 / mm3) achieved for 3 consecutive measurements on 3 different days)
- No (ANC greater than or equal to 0.5 × 109/L (500 / mm3) was not achieved)
- ANC never dropped below 0.5 × 109/L (500 / mm3) at any time after the start of the preparative regimen
- Previously reported – Select this option if subject experienced recovery earlier and this was reported at a prior visit.
Date of ANC recovery:
This field will only appear in the EDC if “Was there evidence of hematopoietic recovery” is answered Yes (ANC greater than or equal to 0.5 × 109/L (500 / mm3) achieved for 3 consecutive measurements on 3 different days). The first of the three days will be designated the day of neutrophil recovery. Date can either be entered directly in the data field using the DD/MMM/YYYY format, or the calendar date picker can be used.
ANC count on day of neutrophil recovery (Day 1):
This field will only appear in the EDC if “Was there evidence of hematopoietic recovery” is answered Yes (ANC greater than or equal to 0.5 × 109/L (500 / mm3) achieved for 3 consecutive measurements on 3 different days). Report the ANC count on the first day of neutrophil recovery in the XXX.XX format which allows for up to three digits before the decimal and two digits after the decimal with units of x 109/L or x 103/uL. Select the appropriate unit of measure from the drop down list next to the numeric entry box.
ANC count (consecutive Day 2):
This field will only appear in the EDC if “Was there evidence of hematopoietic recovery” is answered Yes (ANC greater than or equal to 0.5 × 109/L (500 / mm3) achieved for 3 consecutive measurements on 3 different days). Report the ANC count on the consecutive day 2 of neutrophil recovery in the XXX.XX format which allows for up to three digits before the decimal and two digits after the decimal with units of x 109/L or x 103/uL. Select the appropriate unit of measure from the drop down list next to the numeric entry box.
ANC count (consecutive Day 3):
This field will only appear in the EDC if “Was there evidence of hematopoietic recovery” is answered Yes (ANC greater than or equal to 0.5 × 109/L (500 / mm3) achieved for 3 consecutive measurements on 3 different days). Report the ANC count on the consecutive day 3 of neutrophil recovery in the XXX.XX format which allows for up to three digits before the decimal and two digits after the decimal with units of x 109/L or x 103/uL. Select the appropriate unit of measure from the drop down list next to the numeric entry box.
Platelet Recovery
The following questions refer to initial platelet recovery following the HCT for which this form is being completed. Report the recovery date as the first of three consecutive laboratory values ≥ 20 × 109/L obtained on different days; all dates should reflect no platelet transfusions administered for seven consecutive days, as shown in Example 3 below. Note that platelet recovery may take place well after the subject has returned to the referring physician for care. It is essential that information and laboratory values be obtained from the referring physician.
Transfusions temporarily increase platelet counts. When the data is later used for analysis, it is important to be able to distinguish between a subject whose own body was creating the platelets and a subject who required transfusions to support the counts.
The following example illustrates the procedure to follow for reporting platelet recovery:
Example 3: Reporting Platelet Recovery
Was an initial platelet count of ≥ 20 × 109/L achieved:
Indicate if an initial platelet count of ≥ 20 × 109/L was achieved by selecting the most appropriate response from the following options:
- Yes (Platelet count greater than or equal to 20 × 109/L without a transfusion in the preceding 7 days was achieved)
- No (Platelet count greater than or equal to 20 × 109/L without a transfusion in the preceding 7 days was not achieved)
- Not applicable (Platelet count never dropped below 20 × 109/L at any time post-HCT and a platelet transfusion was never required)
- Previously reported – Select this option if subject experienced recovery earlier and this was reported at a prior visit.
Date platelets >20 × 109/L:
This field will only appear in the EDC if “Was an initial platelet count of ≥ 20 × 109/L achieved” is answered Yes (Platelet count greater than or equal to 20 × 109/L without a transfusion in the preceding 7 days was achieved). The first day of sustained platelet count ≥ 20 × 109/L without a transfusion in the preceding 7 days should be reported. Date can either be entered directly in the data field using the DD/MMM/YYYY format, or the calendar date picker can be used.
Was an initial platelet count of ≥ 50,000/mm3 (or ≥ 50 × 109/L) achieved?:
Indicate if an initial platelet count of ≥ 50,000/mm3 (or ≥ 50 × 109/L) was achieved by selecting the most appropriate response from the following options:
- Yes (Platelet count greater than or equal to 50 × 109/L without a transfusion in the preceding 7 days was achieved)
- No (Platelet count greater than or equal to 50 × 109/L without a transfusion in the preceding 7 days was not achieved)
- Not applicable (Platelet count never dropped below 50 × 109/L at any time post-HCT and a platelet transfusion was never required)
- Previously reported – Select this option if subject experienced recovery earlier and this was reported at a prior visit.
Date platelets ≥ 50,000/mm3 (or ≥ 50 × 109/L) achieved:
This field will only appear in the EDC if “Was an initial platelet count of ≥ 50 × 109/L achieved” is answered Yes (Platelet count greater than or equal to 50 × 109/L without a transfusion in the preceding 7 days was achieved). The first day of sustained platelet count ≥ 50 × 109/L without a transfusion in the preceding 7 days should be reported. Date can either be entered directly in the data field using the DD/MMM/YYYY format, or the calendar date picker can be used.
Was a platelet transfusion given post-transplant since last report?:
Report if a platelet transfusion was given post-transplant since last report. If Yes, Not applicable options for above initial platelet count fields should not be reported.
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