In this example, the sponsor defined a top-level "Analysis Data Class" categorization
| Jira |
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| showSummary | false |
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| server | Issue Tracker (JIRA) |
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| serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
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| key | ARSP-12 |
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, with one or more subcategorizations for each of the data class categories.
This categorization and its subcategorizations are represented—with identifier values assigned for both categorizations and categories—in the reporting event's analysisOutputCategorizations attribute. Note that the categorization and category names represented here are examples of ways in which a sponsor might choose to categorize, and sub-categorize, the analyses or outputs included in a reporting event. They are not intended to be references to any particular Study Data Tabulation Model (SDTM) or ADaM dataset structures....
| Xfancy |
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| Lines 2-4: | - Analysis Data Class (categorization)
| | Lines 5-7: | - Subject-level (category of "Analysis Data Class")
| | Lines 8-10: | - Subject-level Data Type (sub-categorization of "Subject-level")
| | Lines 11-12: | - Demographics (category of "Subject-level Data Type")
| | Lines 13-15: | - Events (category of "Analysis Data Class")
| | Lines 16-18: | - Events Data Type (sub-categorization of "Events")
| | Lines 19-20: | - Adverse Events(category of "Events Data Type")
| | Lines 21-22: | - Clinical Events(category of "Events Data Type")
| | Lines 23-24: | - Disposition(category of "Events Data Type")
| | Lines 25-27: | - Events Analysis Type (sub-categorization of "Events")
| | Lines 28-29: | - Occurrence(category of "Events Analysis Type")
| | Lines 30-31: | - Time-to-Event
| Jira |
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| showSummary | false |
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| server | Issue Tracker (JIRA) |
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| serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
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| key | ARSP-11 |
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(category of "Events Analysis Type")
| | Lines 32-34: | - Findings(category of "Analysis Data Class")
| | Lines 35-37: | - Findings Data Type (sub-categorization of "Findings")
| | Lines 38-39: | - Vital Signs(category of "Findings Data Type")
| | Lines 40-41: | - Laboratory Tests(category of "Findings Data Type")
| | Lines 42-44: | - Findings Analysis Type (sub-categorization of "Findings")
| | Lines 45-46: | - Change from Baseline(category of "Findings Analysis Type")
| | Lines 47-48: | - Shift Table(category of "Findings Analysis Type")
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