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ItemMetadata
ProjectMetadata
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| Item | Label | Unit | Type | Length | Description | CodeList | CodeLabelList | Group | SDTM | Missing | Comment |
| ARMID | Therapy arm | integer | 1 | Therapy arm | 1, 2 | 6 x CHOP-14, 6 x A-CHOP-14 | Therapy arm | ARMID | |||
| GENDER | Gender | integer | 1 | Gender | 0, 1 | male, female | Demographics | SEX | MF | ||
| AGE | Age | years | integer | 2 | Age (years) | Demographics | AGE | ||||
| IPI_AGE | IPI factor age | integer | 1 | IPI factor age>60 years | 0, 1 | age <= 60 years, age > 60 years | Demographics | ||||
| IPI_LDH | IPI factor LDH | integer | 1 | IPI factor LDH>N | 0, 1 | LDH <= N, LDH > N | Demographics | ||||
| IPI_ECOG | IPI factor ECOG | integer | 1 | IPI factor ECOG>1 | 0, 1 | ECOG <= 1, ECOG > 1 | Demographics | ||||
| IPI_STAGE | IPI factor stage | integer | 1 | IPI factor stage III/IV | 0, 1 | stage I/ II, stage III/ IV | Demographics | ||||
| IPI_EXBM | IPI factor E | integer | 1 | IPI factor extralymphatic involvement > 1 | 0, 1 | E <= 1, E > 1 | Demographics | ||||
| IPI | IPI score | integer | 1 | IPI score | Demographics | ||||||
| EXBM | E involvement | integer | 1 | Extralymphatic involvement | 0, 1 | no, yes | Demographics | ||||
| BULK | Bulky disease | integer | 1 | Bulky disease | 0, 1 | no, yes | Demographics | ||||
| BSYMP | B-symptoms | integer | 1 | B-symptoms | 0, 1 | no, yes | Demographics | ||||
| BM | Bone marrow | integer | 1 | Bone marrow involvement | 0, 1 | no, yes | Demographics | ||||
| REFPATHO_T_CELL | Reference pathology (T-cell trials) | integer | 2 | Reference pathology diagnosis | -2, 1, 2, 3, 4, 5, 6, 9, 22, 24, 25 | no T-cell, T-cell lymphoma\, specification of subtype not possible, Peripheral T-cell lymphoma\, unspecified (PTCL-NOS), Angioimmunoblastic T-cell lymphoma (AILT), Anaplastic large cell lymphoma\, ALK-negative, Extranodal NK/T-cell lymphoma\,nasal type, Enteropathy-type T-cell lymphoma, Other T-cell, T-zone variant, Perifollicular variant, Follicular variant | Demographics | ||||
| EFS | EFS time | months | float | 3.4 | Event-free survival (months) | Outcome | |||||
| EFS_STAT | EFS status | integer | 1 | Event-free survival status | 0, 1 | censored, event | Outcome | ||||
| PFS | PFS time | months | float | 3.4 | Progression-free survival (months) | Outcome | |||||
| PFS_STAT | PFS status | integer | 1 | Progression-free survival status | 0, 1 | censored, event | Outcome | ||||
| OS | OS time | months | float | 3.4 | Overall survival (months) | Outcome | |||||
| OS_STAT | OS status | integer | 1 | Overall survival status | 0, 1 | censored, event | Outcome | ||||
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| Metavariable | Value | Comment | |||||||
| ODM_FileOID | ACT-2.xml | A unique identifier for this file. | |||||||
| ODM_Description | Information that will help the receiver interpret the document correctly. | ||||||||
| ODM_ProtocolName | DSHNHL 2006-1B (ACT-2) | This is the sponsor's internal name for the protocol. Defaults to StudyName. | |||||||
| ODM_StudyDescription | Randomised study comparing 6 cycles of chemotherapy with CHOP (Cyclophosphamide, Doxorubicin, Vincristine and Prednisone) at 14-day intervals (CHOP-14), both with or without the monoclonal anti-CD52 antibody alemtuzumab in patients aged 61 to 80 years with T-cell-Lymphoma | This is a free-text description of the study. Defaults to StudyName. | |||||||
| ODM_StudyName | ACT-2 | 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 | Event | 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 | Form | 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 | 2021-05-31T15:44:34 | ||||||||
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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 |
