Clinical laboratory evaluation
iron-deficiency anemia
IRON-DEFICIENCY ANEMIA
There were no notable trends in clinical laboratory findings reported during the study. At day 57, 3 participants (20.0%) showed a decrease in calcium, and at day 85, 3 participants (20.0%) showed an increase in mean corpuscular Hb concentration. These trends were not noted at any other visits, suggesting that they were transient shifts in these participants. There were no trends in coagulation or urinalysis shifts from baseline noted for the pooled data set.Two clinically significant laboratory results (low ferritin and high transferrin) were observed, both in the same participant in cohort 2, at day 183. These out-of-range findings were consistent with the TEAE of iron-deficiency anemia that was captured for this participant on day 30 and was ongoing at the time of database lock. This TEAE was deemed by the investigator to be unrelated to inclacumab.