We've had unplanned requests for connecting rooms, a wheelchair, refrigerators, extra bedding, special food preparation and medical attention.
Their desire for information was even more inspiring because these unplanned requests provided me with an opportunity to deliver additional material, which highlights the value of sometimes not proceeding as planned.
Concomitantly and independently, the FDA requested additional, unplanned post hoc analyses by the sponsor Fresenius Kabi, which were finally agreed upon on 7 May 2012.
Because recruitment was slower than anticipated, our funder (National Institute of Diabetes and Digestive and Kidney Diseases [NIDDK]) requested an unplanned interim analysis, and, based upon this assessment, we terminated recruitment and follow-up with a final sample size of 150 subjects randomized.
The meeting between Mr. Mnuchin and Prince Mohammed was unplanned and came at the request of the Saudis, according to a person familiar with the situation.
With the O'Brien-Fleming-like stopping boundaries, a final adjusted α of 0.08885 is anticipated; however, the final value may be changed depending on unplanned interim analyses (conducted at the request of the DSMB) or slight deviations from the anticipated information milestones (0.5 and 1).
When noticing a potential safety signal in the form of a high total frequency of adverse events, an independent statistician was requested to perform an unplanned interim analysis.
23 In this study, we confirm and extend the results from the initial interim downstaging analysis 23 and report detailed results from an unplanned interim analysis, performed at regulatory agency request, in 222 denosumab-treated patients with evaluable, resectable GCTB whose initially planned curative intent surgery was expected to result in severe morbidity.
10 Some of the changes, however, were classified as having a negative impact on reporting, such as requests by peer reviewers for unplanned additional analyses that were not prespecified in the original trial protocol and that were not reported as such in the final manuscript.
First, this was an unplanned analysis, albeit one undertaken initially at the request of a regulatory body.
At the request of the British National Health Service, 15 an unplanned subgroup analysis was performed that reportedly demonstrated a significant survival benefit in the population with >90% resection of gross tumor but not in those with partial resection.
