We also monitored
occurrences of acute kidney injury or acute
renal failure if they were noted on admission or
occurred during a hospitalization and were reported
in the hospital discharge summary as a
primary or main secondary diagnosis. The Medical
Dictionary for Regulatory Activities was used to
classify the safety events. Coding was performed
at the coordinating center, and up to three codes
were assigned to each safety event. The relationship
of serious adverse events to the intervention
was assessed by the trial safety officer and reviewed
monthly by the safety committee