List Annotations
Export Data
Plot Data
Clear Selection
The data in the text box below can be copied and pasted into Microsoft Excel.
Make sure when pasting the data, "tabs" are selected as the column delimiter.
ItemMetadata
ProjectMetadata
CodingHelp
A
B
C
D
E
F
G
H
I
J
K
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
31
32
33
34
35
| Item | Label | Unit | Type | Length | Description | CodeList | CodeLabelList | Group | STDM | Missing |
| PATSTUID | Patient number | integer | 4 | Patient identification number within trial | Demographics | SUBJID | ||||
| ARMID | Therapy arm | integer | 1 | Therapy arm | 3, 4 | 8 x CHOEP-14 + 6xR, 4 x MegaCHOEP-21 + 6xR | Therapy arm | ARMID | ||
| GENDER | Gender | integer | 1 | Gender | 0, 1 | male, female | Demographics | SEX | ||
| 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 | |||
| AA_IPI | aaIPI score | integer | 1 | age-adjusted 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 | Reference pathology | integer | 4 | Reference pathology diagnosis | 1040, 1044, 1093, 1010, 1080, 1090, 1070, 1035, 1036, 1050, 1060, 1045, 1100, 1000, 1120, 2030, 2060, 3040, 3060, 3050 | 1040, 1044, 1093, 1010, 1080, 1090, 1070, 1035, 1036, 1050, 1060, 1045, 1100, 1000, 1120, 2030, 2060, 3040, 3060, 3050 | 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 | |||
A
B
C
D
E
F
G
H
I
J
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
31
32
33
34
35
| Metavariable | Value | Comment | |||||||
| ODM_FileOID | MegaCHOEP-III.xml | A unique identifier for this file. | |||||||
| ODM_Description | Information that will help the receiver interpret the document correctly. | ||||||||
| ODM_ProtocolName | MegaCHOEP-III | This is the sponsor's internal name for the protocol. Defaults to StudyName. | |||||||
| ODM_StudyDescription | MegaCHOEP-III | This is a free-text description of the study. Defaults to StudyName. | |||||||
| ODM_StudyName | MegaCHOEP-III | 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 | 2018-03-28T15:37:56 | ||||||||
A
B
C
D
E
F
G
H
I
J
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
31
32
33
34
35
| 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 | |
