TY - JOUR AU - Wittes, Janet AU - Palensky, Jolie AU - Asner, Debra AU - Julian, Desmond AU - Boissel, Jean-Pierre AU - Furberg, Curt D. AU - Kulbertus, Henri AU - Pocock, Stuart AU - Roniker, Barbara PY - 2001 DA - 2001/02/07 TI - Experience collecting interim data on mortality: an example from the RALES study JO - Current Controlled Trials in Cardiovascular Medicine SP - 59 VL - 2 IS - 1 AB - The Randomized Aldactone Evaluation Study (RALES) randomized 822 patients to receive 25 mg spironolactone daily and 841 to receive placebo. The primary endpoint was death from all causes. Randomization began on March 24, 1995; recruitment was completed on December 31, 1996; follow-up was scheduled to continue through December 31, 1999. Evidence of a sizeable benefit on mortality emerged early in the RALES. The RALES data safety monitoring board (DSMB), which met semiannually throughout the trial, used a prespecified statistical guideline to recommend stopping for efficacy. At the DSMB's request, its meetings were preceded by an 'endpoint sweep', that is, a census of all participants to confirm their vital status. SN - 1468-6694 UR - https://doi.org/10.1186/cvm-2-1-059 DO - 10.1186/cvm-2-1-059 ID - Wittes2001 ER -