SEC Seconds
MIN Minutes
HR Hours
DAY Days
WK Weeks
MON Months
YR Years
---- ------------
CODE MEANING TEXT
Unit abbreviation for duration of therapy (see table below)
Numeric value of the duration (length) of therapy
YYYYMM-onlys are converted to midpoint of month: YYYYMM15
YYYY-onlys are converted to midpoint of year: YYYY0702
See the NOTE on dates at the end of this section.
If a complete date not available, a partial date will be provided.
A date therapy was started (or re-started) for this drug.
(YYYYMMDD) – If a complete date not available, a partial date is provided.
with the appropriate drug listed in the case using the PRIMARYID.
of linking the data elements in each individual file together
Indication, and Therapy files, respectively, all serve the same purpose
Additionally, the fields labeled DRUG_SEQ, INDI_DRUG_SEQ, and DSG_DRUG_SEQ in the Drug,
The Drug Seq # simply shows the order of the DRUGNAME within a unique case.
NOTE:  The Drug Seq # is no longer a unique key as was the case in LAERS QDE.
30781401     1                    19970620
30781401     1                    199704            19970613
---         ----------       --------          ------
PRIMARYID   DSG_DRUG_SEQ #   START_DT          END_DT
they do not appear in the Drug Therapy file, which is excerpted as follows:
No therapy dates were reported for the concomitants; therefore,
(or DSG_DRUG_SEQ # as it is called in the Therapy file - see below).
In such a circumstance, the two entries will have the same PRIMARYID and the same DRUG_SEQ #
Since the drug was started, stopped, then restarted, there are two entries in the Drug Therapy file.
Dates of therapy for Aricept were reported as "4/97 to 6/13/97", and "6/20/97 (ongoing)."
30781401         4            Synthroid (Levothyroxine Sodium)
30781401         3            Prozac( Fluoxetine Hydrochloride
30781401         2            Estrogens
30781401         1            Aricept
---             --------       --------
PRIMARYID       DRUG_SEQ       DRUGNAME
Primaryid 30781401 appears four times in the Drug file, with a different DRUG_SEQ for each drug:
Four drugs were reported for this Case: Aricept was reported as suspect, and Estrogens, Prozac, and Synthroid as concomitant.
30781401
---
PRIMARYID
Like any Case, it appears once (and only once) in the Demographic file:
The PRIMARYID for this case is 30781401.
Consider Case 3078140 version 1, received by the FDA on 12/31/97.
and the therapy date(s) reported for the drug(s).
This will also clarify the relationship between a Case, the drug(s) reported for that Case,
The best way to explain the DRUG_SEQ (drug sequence number) is with an example.
DRUG_SEQ (Drug file, Therapy file, and Indications file).
see Section E, End Note 2, below.)
(For an explanation of the DRUG_SEQ number, including an example,
and the DRUG_SEQ number (secondary key) are needed.
To link to the DRUGyyQq.TXT data file, both the Case number primary key)
Drug sequence number for identifying a drug for a Case.
will have the same CASE number as the initial/oldest version.
A follow-up version (that is, the newest/latest version received by FDA)
A case consists of one or more versions.
Number for identifying a FAERS case (example. 3123456).
It is the Identifier for the case sequence (version) number as reported by the manufacturer.
This is a concatenated key of Case ID and Case Version Number.
This is the primary link field (primary key) between data files (example: 31234561).
Unique number for identifying a FAERS report.
(0 or more per drug per event).
THERyyQq.TXT contains drug therapy start dates and end dates for the reported drugs
by Jean Roth , jroth@nber.org ,  7 Apr 2017