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ItemMetadata
ProjectMetadata
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| Item | Label | Unit | Type | Length | Description | CodeList | CodeLabelList | Group | SDTM | Missing | Comment |
| subject_key | subject_key | string | 16 | <IGNORE> | SUBJID | ||||||
| death_28 | 28d Mortalitaet | integer | 8 | 0, 1 | Survior, Non-Survivor | primärer Endpunkt | |||||
| death_90 | 90d Mortalitaet | integer | 8 | 0, 1 | Survior, Non-Survivor | sekundärer Endpunkt | |||||
| lits | ITS-Liegedauer [in Tagen] | d | integer | 8 | sekundärer Endpunkt | ||||||
| msofa | mittlerer SOFA | float | 8.2 | sekundärer Endpunkt | |||||||
| msofacir | mittlerer SOFA-Subscore Kreislauf | float | 8.2 | sekundärer Endpunkt | |||||||
| msofapul | mittlerer SOFA-Subscore Pulmo | float | 8.2 | sekundärer Endpunkt | |||||||
| msofacoa | mittlerer SOFA-Subscore Gerinnung | float | 8.2 | sekundärer Endpunkt | |||||||
| msofaren | mittlerer SOFA-Subscore Niere | float | 8.2 | sekundärer Endpunkt | |||||||
| msofahep | mittlerer SOFA-Subscore Leber | float | 8.2 | sekundärer Endpunkt | |||||||
| msofacns | mittlerer SOFA-Subscore ZNS | float | 8.2 | sekundärer Endpunkt | |||||||
| aehypo | AE Hypoglykaemie | integer | 8 | 0, 1 | nein, ja | sekundärer Endpunkt | |||||
| net | Einsatz von Nierenersatzverfahren | integer | 8 | 0, 1 | nein, ja | sekundärer Endpunkt | |||||
| renfail | akutes Nierenversagen | integer | 8 | 0, 1 | nein, ja | sekundärer Endpunkt | |||||
| vpfd | Vasopressoren-freie Tage | integer | 8 | sekundärer Endpunkt | |||||||
| eryk_h | Erythrozytenkonzentrate | integer | 8 | 0, 1 | nicht verabreicht, verabreicht | sekundärer Endpunkt | |||||
| erykd_h | Gesamtanzahl Erythrozytenkonzentrate | integer | 8 | sekundärer Endpunkt | |||||||
| ventfd_21d | Beatmungsfreie Tage unter Studienther... | integer | 8 | sekundärer Endpunkt | |||||||
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| Metavariable | Value | Comment | |||||||
| ODM_FileOID | VISEP_endpunkte.xml | A unique identifier for this file. | |||||||
| ODM_Description | Information that will help the receiver interpret the document correctly. | ||||||||
| ODM_ProtocolName | VISEP | This is the sponsor's internal name for the protocol. Defaults to StudyName. | |||||||
| ODM_StudyDescription | VISEP | This is a free-text description of the study. Defaults to StudyName. | |||||||
| ODM_StudyName | VISEP | This is a short external name for the study, is also used as OID | |||||||
| ODM_StudyEventMandatory | Yes | Indicates that the clinical data for the containing MetaDataVersion would be incomplete without an instance of this type of Study Event | |||||||
| ODM_StudyEventName | Endpunkte | Unique Name, is also used as OID. Defaults to 'Event'. | |||||||
| ODM_StudyEventOrderNumber | 1 | ||||||||
| ODM_StudyEventRepeatKey | empty if non repeating, <AUTOMATIC> for automatic counter otherwise Variable Reference (Variable.<Name>) | ||||||||
| ODM_MetaDataVersionName | Name of Metadata version | ||||||||
| ODM_MetaDataVersionOID | v1.0.0 | Metadata version ID. | |||||||
| ODM_FormMandatory | Yes | Indicates that the clinical data for an instance of the containing study event would be incomplete without an instance of this type of form | |||||||
| ODM_FormName | Endpunkte | Unique Name, is also used as OID. Defaults to 'Form'. | |||||||
| ODM_FormRepeatKey | empty if non repeating, <AUTOMATIC> for automatic counter otherwise Variable Reference (Variable.<Name>) | ||||||||
| ODM_ItemGroupMandatory | Yes | Indicates that the clinical data for an instance of the containing form would be incomplete without an instance of this type of item group | |||||||
| ODM_ItemGroupRepeatKey | empty if non repeating, <AUTOMATIC> for automatic counter otherwise Variable Reference (Variable.<Name>) | ||||||||
| ODM_ItemMandatory | Yes | Indicates that the clinical data for an instance of the containing item group would be incomplete without an instance of this type of item. | |||||||
| Source_CSV_Charset | ISO-8859-1 | Data source file encoding. | |||||||
| Source_CSV_Delimiter | ; | Data source file delimiter. | |||||||
| Source_CSV_Header | Yes | Data source first row contains header. | |||||||
| Source_CSV_Quote | " | Data is enclosed in | |||||||
| ODM_AsOfDateTime | 2019-02-11T11:56:08 | ||||||||
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| DO NOT CHANGE THIS SHEET | |||||||||
| DataType | date | datetime | float | integer | partialDate | text | time | ||
| YesNo | Yes | No | |||||||
| Source_CSV_Charset | ISO_8859_1 | UTF-8 | |||||||
| Source_CSV_Delimiter | \t | , | ; | ||||||
| STDM | AGE | SEX | STUDYID | ARMCD | VISITNUM | BRTHDTC | SVSTDTC | SVENDTC | SUBJID |
