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Posted On: 01/18/2021 12:50:13 AM
Post# of 153776
Either our DMC was out to get a failure from the start, or they could plainly see an increase in cohort size *and* an increase of dosing really and truly weren't necessary, as stat sig for a completed trial was being met.
It's that simple. The 42 days @ 75% was an attempt to deal with slow summer enrollment, and they saw deaths in SOC past 28 days that could've pushed significance to the point of stoppage.
And we just went over what it meant if deaths past 28 days have been reported... Those are assumed to be under 28 days in the LLMab arm in most people's current models.
It's that simple. The 42 days @ 75% was an attempt to deal with slow summer enrollment, and they saw deaths in SOC past 28 days that could've pushed significance to the point of stoppage.
And we just went over what it meant if deaths past 28 days have been reported... Those are assumed to be under 28 days in the LLMab arm in most people's current models.
Quote:
He made this request to the DSMC at our 50% Interim Analysis. According to Dr. Lalezari, he was told that adding the additional dosing was not necessary.
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