Skip to main content

Table 4 Non-fatal SAEs and neurological sequelae by fluid arm

From: 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

  Non-fatal SAEs and neurological sequelaea 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: 13b NS: 10b NS: 7b NS: 20b
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
  1. NFSAE: non-fatal serious adverse event, RICP = raised intracranial pressure, PE = pulmonary edema, AR = allergic reaction, NS = neurological sequelae.
  2. aeither reviewed and accepted by the ERC or not reviewed at the time of the report.
  3. 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.