As the pre-defined safety criteria protocol specified, there were a number of patients removed prior to end of study for reasons of safety/anemia management. Due to pre-defined reasons of safety/anemia management (see pre-defined safety criteria under Study Design, above), 69 patients were removed in the SFP arm and 83 were removed in placebo. Due to anemia related protocol violations (IV iron or ESA given), 19 patients were removed from the study in the SFP arm and 22 in placebo. 1 patient was removed in the SFP arm and 7 patients in placebo due to blood transfusions. Other reasons for early termination were balanced between the groups.
Which I believe it was stated this was normal. They could not vary the range of the dosage during the trial where in real life they could. It takes a while to identify the right strength.
As management stated, they were not concerned about this
the 22 in the placebo probably had to be removed as their condition was getting worse