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. 2013 Mar 26;14:85. doi: 10.1186/1745-6215-14-85

Table 2.

IDMC recommendations from first four meetings

 
First Meeting (25 February 2009):

Requested details of adverse event reporting and listings of all individual events by patient identification
Second Meeting (18 June 2009):

Requested information on children screened for the trial but not enrolled

Requested the number and quantity of additional fluids (other than boluses) given to all children

Asked the study teams to make extra effort to ensure that all children attend for neurological examination at 28 days
Third meeting (12 October 2009):

Endorsed the review procedure for SAE proposed, and stressed the importance of blinded review by the ERC

Accepted co-enrollment of children into other studies

Noted planned sub-studies
Fourth meeting (26 January 2010, third interim analysis):

Observed improvement in attendance for neurological follow up at 28 days

Referred the request by a local IRB for representation on the IDMC to the TSC

Requested more detailed information on all fluids received in each arm by time from randomization
Agreed with the proposed plan of analysis