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RegisterAnalysis Sets and Handling of Dropouts and Missing Values [RSABE / ABEL]
Hi,
We are currently in the planning stages of a BE trial for a HVD. The current proposed study design is a 2x2x4. We are planning on performing a RSABE analysis.
My question has two parts. First, how are analysis sets defined for a RSABE analysis? Must subjects complete all 4 periods in order to be included in the analysis population? How are dropouts and missing values handled.
For example, what if a subject drops from the study after completing periods 1 & 2. Or, what if a subject vomits during one of the periods?
Any guidance or suggestions is greatly appreciated.
Thanks!
We are currently in the planning stages of a BE trial for a HVD. The current proposed study design is a 2x2x4. We are planning on performing a RSABE analysis.
My question has two parts. First, how are analysis sets defined for a RSABE analysis? Must subjects complete all 4 periods in order to be included in the analysis population? How are dropouts and missing values handled.
For example, what if a subject drops from the study after completing periods 1 & 2. Or, what if a subject vomits during one of the periods?
Any guidance or suggestions is greatly appreciated.
Thanks!
Complete thread:
- Analysis Sets and Handling of Dropouts and Missing Valuesmunsoned 2016-05-04 03:53
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Dropouts and Missing Values in RSABE d_labes 2016-05-04 09:27
Ing. Helmut Schütz