JLang, Enrollment increased to 515, with next a
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Posted On: 01/20/2021 8:29:07 AM
JLang,
Enrollment increased to 515, with next analysis at 75%, which has not been announced.
Excerpt from Humanigen PR:
“At the recommendation of the DSMB, the company plans to increase enrollment to achieve 402 events (approximately 515 patients). This increase in enrollment ensures an even higher probability of success in meeting the primary endpoint and maintains the power of the study at 90 percent. The next interim analysis for efficacy is planned when the study reaches 75 percent events (302 events) which will require approximately 390 patients to be enrolled in the trial.”
https://s27.q4cdn.com/938944131/files/doc_new...0f36a3.pdf
Enrollment increased to 515, with next analysis at 75%, which has not been announced.
Excerpt from Humanigen PR:
“At the recommendation of the DSMB, the company plans to increase enrollment to achieve 402 events (approximately 515 patients). This increase in enrollment ensures an even higher probability of success in meeting the primary endpoint and maintains the power of the study at 90 percent. The next interim analysis for efficacy is planned when the study reaches 75 percent events (302 events) which will require approximately 390 patients to be enrolled in the trial.”
https://s27.q4cdn.com/938944131/files/doc_new...0f36a3.pdf
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