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FDA Safety Tables and Figures
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[New Table]: Table 44 #194

Open jknizia opened 8 months ago

jknizia commented 8 months ago

Table Layout & Design

image

Please refer to page 82 of the FDA guideline document for more details.

Table Description

Table 44. Listing of Patients With Adverse Events Leading to Treatment Discontinuation From Study Drug, Safety Population, Pooled Analysis

Analysis Datasets

ADAE ADSL

Data from the random.cdisc.data package, can be retrieved by random.cdisc.data::c followed by your dataset name.

Analysis Filters

Safety population: SAFFL == "Y" Patients With Adverse Events Leading to Treatment Discontinuation From Study Drug: AEWITHFL == "Y"

Additional Information

No response

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