3.5 Label File

The Label File is optional and is used to customize labels of elements in the report—e.g., groups, column headers, etc. If the Label File is not specified, default labels will be applied to all report elements.


Figure 3.1: LABELFILE Example

Table 3.7: LABELFILE specification
Parameter Field Name Description
GROUP/ANALYSISGRP/MILGRP to include in report GROUP Name of each cohort or analysis to include in report.
Note 1: GROUP must correspond to values of COHORTGRP/ANALYSISGRP/MILGRP included in distributed input files.
Note 2: for Type 6 (Manufacturer-Level Product Utilization and Switching Pattern) reports, include COHORTGRP values if requesting medical product utilization tables and/or ANALYSISGRP values if requesting switching tables.
Note 3: if a GroupLabel is not assigned for a group, the GROUP name will be displayed.
Note 4: if LABELTYPE is report-level, leave GROUP blank.
Format: SAS character $40; no special characters (e.g., commas, periods, hyphens, spaces, etc.) allowed, and underscores must be used to mark spaces.
Example: insulin
RunID Corresponding to GROUP RUNID RunID assigned to the run that corresponds to the group or analysis name listed in GROUP
Note 1: if LABELTYPE is report-level, leave RUNID blank.
Format: SAS character $5
Example: r01
Type of Label LABELTYPE Label to describe analyses in report titles.
Valid values are:
Report-Level LABELTYPEs:
  • ReportTitle: Label to describe analyses in report titles
  • CensorLabel: Label for censoring criteria
  • CFDDCatLabel: Label for category of current filled daily dose in Type 5 report
  • AFDDCatLabel: Label for category of average filled daily dose in Type 5 report
  • CumDoseCatLabel: Label for category of cumulative dose in Type 5 report
Group-Level LABELTYPEs:
  • BaselineLabel: Label for L1 baseline table
  • GroupLabel: Label for GROUP
  • OutcomeLabel: Label for outcome of interest
  • Intervention1Label (Not yet functional): Label for intervention 1 in ITS analysis
  • Intervention2Label (Not yet functional): Label for intervention 2 in ITS analysis
  • ITSComparisonLabel (Not yet functional): Label for ITS comparison
  • AdherenceLabel (Not yet functional): Label for adherence criteria
  • Header: Label to group multiple GROUPs under a single header
  • MOILabel: Label for medical product of interest in Type 4 report
  • MOIHeader: Label to group multiple medical products of interest under a single header in Type 4 report
Note 1: if >1 GROUP is included in 1 baseline table (using BASELINEGROUPNUM parameter in Baseline File), then the LABEL value for LABELTYPE = BaselineLabel should be the same for the two GROUPs appearing on the same table. Otherwise the program will default to LABEL value for the first GROUP listed.
Note 2: if LABELTYPE = AdherenceLabel, MOILabel, MOIHeader, CensorLabel, CFDDCatLabel, AFDDCatLabel, or CumDoseCatLabel, then LABELVAR must be specified.
Note 3: if no Header label is specified, all GROUPs will be displayed together with no header. If no MOIHeader label is specified, all medical products of interest will be displayed together with no header.
Note 4: if LABELTYPE is report-level, leave GROUP and RUNID blank.
Note 5: if ReportTitle is not defined, the default label “Exposures of Interest” will be used.
Format: SAS character $30
Example: ReportTitle
Variable to Relabel LABELVAR Specifies the variable referred to by LABEL.
Valid values are:
If LABELTYPE = CensorLabel:
  • cens_elig: Disenrollment
  • cens_dth: Evidence of Death
  • cens_dpend: End of Data
  • cens_qryend: End of Study Period
  • cens_episend: End of Exposure Episode
  • cens_spec: Occurrence of User-Defined Censoring Criteria
  • cens_event: Occurrence of Outcome of Interest
  • cens_switch1: First Switch
  • cens_switch2: Second Switch
If LABELTYPE = CFDDCatLabel, AFDDCatLabel, or CumDoseCatLabel:
  • dosecat#: # corresponds to dose category number in Type 5 analysis
If LABELTYPE = MOILabel or MOIHeader:
  • MP#: # corresponds to medical product of interest number in Type 4 analysis
Format: SAS character $32
Example: cens_spec
Label to Apply LABEL Label (display name) for report element specified in LABELTYPE.
Format: SAS character - length can vary
Example: Beta Blockers

3.5.1 Key Variables

The labelfile key variables are GROUP, RUNID, LABELTYPE, and LABELVAR. Users will who require multiple MOIHeaders will need to create two rows per MOI, one for LABELTYPE = MOILabel and one for LABELTYPE = MOIHeader. Table 3.8 illustrates this.
Table 3.8: Specifying multiple MOIHeaders
Labeltype Labelvar Label
moilabel MP1 Acamprosate
moiheader Analgesics, Anesthesia, and Drugs of Abuse
moilabel MP2 Cocaine
moiheader Analgesics, Anesthesia, and Drugs of Abuse