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This is an example of an ADAE dataset and is based primarily on input from the SDTM AE dataset. Other adminstrative administrative data about the subjects are based on the ADSL datset dataset provided in Section 3.3.. > add the link6.1, Subject-level Analysis Dataset (ADSL). Only variables needed for illustration are shown in the examples. Below
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This is |
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an example of the input SDTM AE datasets used to create the ADAE. |
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Need to Determine Codes to be used TRIAL INTERVENTION DISCONTINUED or PRODUCT DISCONTINUED Need to look Up code for MEDDRA SKIN REDNESS |
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Below is the example ADAE dataset and associated metadata.
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| Name | ADAE |
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STUDYID
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| Level | Dataset |
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| Purpose | Analysis |
| Name | ADAE |
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| Dataset | ADAE |
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| Level | Variable |
| Purpose | Analysis |
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STUDYID
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Created from converting AE.AESTDTC from character ISO8601 format to numeric date format
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Created from converting AE.AEENDTC from character ISO8601 format to numeric date format
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The example ADAE dataset and associated metadata serve as an example and are not intended to indicate that ADAE must be used as the dataset name, nor are the parameters described necessarily those that would be used in a particular study.
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