This dedicated lithospheric field inversion (DLFI) is the one currently used to produce one of the official ESA level 2 candidate products in the framework of the Swarm Satellite Constellation Application and Research Facility (SCARF; Olsen et al. 2013).
For patients within the FDA-recommended hematocrit range of 30 – 36%, the change in ESA level immediately after the warnings was not significant, but there was a decline in month-to-month trend after the warnings (−103 U/wk, p =0.014).
Patients with a hematocrit ≥36% had a declining month-to-month trend before (−164 units/week, p = <0.0001) and after the warnings (−80 units/week, p = .001), and a large drop in ESA level immediately after the black box (−4,744 units/week, p = <.0001).
For example, patients with a hematocrit ≥36% had a declining month-to-month trend both before (−164 units/week, p = <.0001) and after the warnings (−80 U/wk, p = .001), and a large drop in ESA levels after the warnings (−4,744 U/wk, p = <.0001).
For ESA-resistant patients, those with the highest doses and hematocrit levels <30%, there was a large increase in ESA dose level immediately after the warnings (and no subsequent significant decline in ESA trend); findings contrary to the FDA black box warning.
Magnetic field, navigation, accelerometer, plasma and electric field measurements are provided by ESA as Level 1b data, which consist of calibrated and formatted time series of the observations.
The drop in ESA dose level after the warnings was also not significant.
In contrast, patients with a hematocrit <30% had a large increase in ESA dose level after the warnings (6,220 U/wk, p = .013), consistent with an increasing month-to-month trend before the warnings (224 units/week, p = .01).01
Chain 1 patients experienced a declining month-to-month trend before (−90 units/week, p = .004) and after the warnings (−103 U/wk, p = .002), and a drop in ESA dose level after the warnings (−2,148 U/wk, p = .017).017
And Chain 3 patients experienced an increasing month-to-month trend before the warnings (94 U/wk, p = .041), and an increase in the ESA dose level after the warnings (3,189 U/wk, p = .016), followed by a flat insignificant trend.
Patients who had the highest hematocrit values showed the largest shift or decline in ESA dose level after the FDA warning with a drop of 4,744 U/week, perhaps because providers were concerned about their safety given publication of CHOIR [ 7] and CREATE [ 8] findings in mid-November 2006, showing potential harm and no benefit for ESA therapy, respectively.
