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 |