When enough is enough: how the decision was made to stop the FEAST trial: data and safety monitoring in an African trial of Fluid Expansion As Supportive Therapy (FEAST) for critically ill children

Table 3 Mortality in FEAST A presented in each IDMC report

					Comparisons between arms for mortality at 48 hours
	Mortality in each arm				Primary endpoint		Secondary endpoint
Meeting	Albumin	Saline	Control	Total	Risk ratio for saline bolus versus no bolus	Risk ratio for albumin bolus versus saline bolus	Risk ratio bolus versus no bolus
18 June 2009 (data to 13 May 2009); N = 406	12/137 (8.8%)	14/136 (10.3%)	18/133 (13.5%)	44/406 (10.8%)	0.76 (0.39 to 1.47);P = 0.41	0.87 (0.42 to1.81); P = 0.71	0.70 (0.40 to 1.24); P = 0.22
12 October 2009 (data to 31 August 2009); N = 844	30/283 (10.6%)	28/282 (9.9%)	31/279 (11.1%)	89/844 (10.5%)	0.89 (0.06 to 1.45); P = 0.65	1.07 (0.66 to 1.74); P = 0.79	0.92 (0.61 to 1.39); P = 0.71
26 January 2010 (data to 31 December 2009); N = 1,337	50/444 (11.3%)	46/445 (10.3%)	43/448 (9.6%)	139/1337 (10.4%)	1.07 (0.73 to 1.60); P = 0.71	1.09 (0.75 to 1.59); P = 0.66	1.13 (0.78 to 1.58); P = 0.50
26 July 2010 (data to 15 June 2010); N = 2,196	74/732 (10.1%)	74/733 (10.1%)	56/731 (7.7%)	204/2196 (9.3%)	1.32 (0.95 to 1.84); P = 0.10	1.001 (0.74 to 1.36); P = 0.99	1.32 (0.98 to 1.77); P = 0.06
12 January 2011 (data to 15 November 2010); N = 2,987	101/989 (10.2%)	101/989 (10.2%)	69/989 (7.0%)	271/2987 (9.1%)	1.46 (1.09 to 1.96);P = 0.01	1.00 (0.77 to 1.30); P = 1.0	1.46 (1.13 to 1.90);P = 0.004

ISSN: 1745-6215