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PlentyParanoid

11/25/18 12:23 PM

#249777 RE: loanranger #249761

Can someone explain what is done between the Primary and Study Completion Dates that takes 4 years to do?

The time difference is usually due to secondary measures. Galera probably wants to see if GC4419 inhibits tumor growth and hence improves survival time and has included survival analysis in secondary measures. Waiting sufficient number of people to die takes a long time. Cancer study part does not prevent Galera from filing for SOM after SOM related studies are done.

kfcyahoo

11/25/18 1:59 PM

#249790 RE: loanranger #249761

LR,

From the following link- https://clinicaltrials.gov/ct2/about-studies/glossary
Note words high lighted appear in both fefinition, words in bold type appear only one of the definitions.

Primary completion date
The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "estimated" primary completion date is the date that the researchers think will be the primary completion date for the study.


Study completion date
The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "estimated" study completion date is the date that the researchers think will be the study completion date.