DSMB reports

Met with Eric today and went over some tables that are generated each study period. Some time-specific sequences:

  • Data collection will stop about 4-6 weeks out from the time the DSMB meeting is to occur (to give the CTC time to collect and clean data and to get reports out to the DSMB committee)
  • Meeting is every 3 months (but they might not enroll enough patients given the 5/2015 cutoff)

Some new concepts:

  • Consort diagram – flowchart describing at how they got at the analysis population
  • TEG – thromboelastography: measurement of efficiency of blood coagulation
  • DRS (outcome) – disability rating score: alternative (secondary) measurement of outcome
  • GOSE (1* outcome) – Glasgow outcome score, extended: measure of brain functioning (1=dead, 8=OK)
  • Key SAE’s:
    • DVT – deep vein thrombosis
    • MI – myocardial infarction
    • PE – pulmonary embolism
    • seizures

Statistical issues:

  • A measurement of progression is from head CT scans. Of particular interest is the progression of blood (clots/presence/size) on the CT scan(s) but it requires surviving to the second (or later) CT. Question is if there’s confounding (in survival, in the treatment effect, or something else) that’s affecting whether or not the second CT is observed, which will change the interpretation of “CT scan blood clot progression” or the like based on how the sample was obtained.
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