Page History
Occurrence flags can be used to prepare data for analysis. They are typically created by sorting the data in the required order and then flagging the first treatmentproduct-emergent record. The use of the word “first” in this section does not necessarily mean chronological, although that is an option. The more common occurrence flags and a structure for additional flags are shown below
OCCDS Occurrence Flag Variables
...
Variable Name
...
Variable Label
...
Type
...
Codelist
...
Controlled Terms
...
Core
...
SubClass ADVERSE EVENT Core
...
CDISC Notes
...
AOCCFL
...
1st Occurrence within Subject Flag
...
Char
...
Y
...
Perm
...
Perm
...
Character indicator for the first occurrence of any event/intervention/finding within the subject
Example derivation: Sort the data in the required order and flag the first treatment emergent record for each subject.
...
AOCCPFL
...
1st Occurrence of Preferred Term Flag
...
Char
...
Y
...
Perm
...
Perm
...
Character indicator for the first occurrence of the preferred term within the subject Example derivation: Sort the data in the required order and flag the first treatment emergent record for each --DECOD for each subject.
...
AOCCIFL
...
1st Max Sev./Int. Occurrence Flag
...
Char
...
Y
...
Perm
...
Perm
...
Character indicator for the first occurrence of the event/intervention/finding with the maximum severity/intensity within the subject
Example derivation: Sort the data in the required order and flag the first treatment emergent record for maximum severity for each subject.
...
AOCCPIFL
...
1st Max Sev./Int. Occur Within PT Flag
...
Char
...
Y
...
Perm
...
Perm
...
Character indicator for the first occurrence of the maximum severity/intensity within the subject and preferred term
Example derivation: Sort the data in the required order and flag the first treatment emergent record for maximum severity within preferred term for each subject.
...
AOCCzzFL
...
1st Occurrence of ...
...
Char
...
Y
...
Perm
...
Perm
...
Additional flag variables as needed for analysis. Derivation rules for these flags need to be described in the metadata.
| Include Page | ||||
|---|---|---|---|---|
|
MedDRA Occurrence Flag Variables
| Include Page | ||||
|---|---|---|---|---|
|
MedDRA Occurrence Flag Variables
...
Variable Name
...
Variable Label
...
Type
...
Codelist
...
Controlled Terms
...
Core
...
SubClass ADVERSE EVENT Core
...
CDISC Notes
...
AOCCSFL
...
1st Occurrence of SOC Flag
...
Char
...
Y
...
Perm
...
Perm
...
Character indicator for the first occurrence of the system organ class within the subject
Example derivation: Sort the data in the required order and flag the first treatment- emergent record for each body system for each subject.
...
AOCCSIFL
...
1st Max Sev./Int. Occur Within SOC Flag
...
Char
...
Y
...
Perm
...
Perm
Character indicator for the first occurrence of the maximum severity/intensity within the subject and system organ class
...
| Pagenav |
|---|
Overview
Content Tools