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 4 Non-fatal SAEs and neurological sequelae by fluid arm

	Non-fatal SAEs and neurological sequelae^a in each arm
Meeting	Albumin	Saline	Control	Total
18 June 2009 (data to 13 May 2009); N = 406	NFSAE: 2	NFSAE: 1	NFSAE: 2	NFSAE: 5
	RICP: 1	other: 1	AR: 1	RICP: 1
	AR: 1		other: 1	AR: 2
				other:2
	NS: 5	NS: 4	NS: 3	NS : 11
12 October 2009 (data to 31 August 2009); N = 844	NFSAE: 3	NFSAE: 2	NFSAE: 2	NFSAE: 7
	RICP: 1	AR: 1	AR: 2	RICP: 1
	AR: 1	other: 1		AR: 3
	other: 1			other: 2
	NS: 9	NS: 12	NS: 5	NS: 16
26 January 2010 (data to 31 December 2009); N = 1,337	NFSAE: 3	NFSAE: 4	NFSAE: 3	NFSAE: 10
	RICP: 1	AR:2	AR: 2	RICP: 1
	AR: 1	other: 2	other: 1	AR: 5
	other: 1			other: 4
	NS: 14	NS: 17	NS: 9	NS: 30
26 July 2010 (data to 15 June 2010); N = 2,196	NFSAE: 4	NFSAE: 8	NFSAE: 4	NFSAE: 16
	RICP: 1	RICP: 1	AR: 3	RICP: 2
	AR: 2	AR: 4	other: 1	AR: 9
	other: 1	other: 3		other: 5
	NS: 13^b	NS: 10^b	NS: 7^b	NS: 20^b
12 January 2011 (data to 15 November 2010); N = 2,987	NFSAE: 6	NFSAE: 8	NFSAE: 5	NFSAE: 19
	PE: 1	RICP: 1	RICP: 1	PE: 1
	- RICP: 1	- AR: 4	- AR: 3	- RICP: 3
	AR: 3	other: 3	other:1	AR: 10
	other: 1			other: 5
	NS: 22	NS: 16	NS: 10	NS: 38

NFSAE: non-fatal serious adverse event, RICP = raised intracranial pressure, PE = pulmonary edema, AR = allergic reaction, NS = neurological sequelae.
^aeither reviewed and accepted by the ERC or not reviewed at the time of the report.
^bthe definition of neurological sequelae was refined between the reports in 2010 to take into account information about whether each ‘abnormal neurological finding’ at 28 days was an existing condition at baseline. Thus, children with a known neurological abnormality at baseline that had not deteriorated during follow-up were not included in the neurological sequelae numbers from that point onwards.

ISSN: 1745-6215