_dta: 1. by Jean Roth , jroth@nber.org , 26 Mar 2015 2. INDIyyQq.TXT contains all "Medical Dictionary for Regulatory Activities" (MedDRA) terms 3. coded for the indications for use (diagnoses) for the reported drugs (0 or more per drug per event). primaryid: 1. Unique number for identifying a FAERS report. 2. This is the primary link field (primary key) between data files (example: 31234561). 3. This is a concatenated key of Case ID and Case Version Number. 4. It is the Identifier for the case sequence (version) number as reported by the manufacturer. indi_drug_seq: 1. Drug sequence number for identifying a drug for a Case. 2. To link to the DRUGyyQq.TXT data file, both the Case number 3. (primary key) and the DRUG_SEQ number (secondary key) are needed. 4. (For an explanation of the DRUG_SEQ number, including an example, 5. see Section E, End Note 2, below.) 6. DRUG_SEQ (Drug file, Therapy file, and Indications file). 7. The best way to explain the DRUG_SEQ (drug sequence number) is with an example. 8. This will also clarify the relationship between a Case, the drug(s) reported for that Case, 9. and the therapy date(s) reported for the drug(s). 10. Consider Case 3078140 version 1, received by the FDA on 12/31/97. 11. The PRIMARYID for this case is 30781401. 12. Like any Case, it appears once (and only once) in the Demographic file: 13. PRIMARYID 14. --- 15. 30781401 16. Four drugs were reported for this Case: Aricept was reported as suspect, and Estrogens, Prozac, and Synthroid as concomitant. 17. Primaryid 30781401 appears four times in the Drug file, with a different DRUG_SEQ for each drug: 18. PRIMARYID DRUG_SEQ DRUGNAME 19. --- -------- -------- 20. 30781401 1 Aricept 21. 30781401 2 Estrogens 22. 30781401 3 Prozac( Fluoxetine Hydrochloride 23. 30781401 4 Synthroid (Levothyroxine Sodium) 24. Dates of therapy for Aricept were reported as "4/97 to 6/13/97", and "6/20/97 (ongoing)." 25. Since the drug was started, stopped, then restarted, there are two entries in the Drug Therapy file. 26. In such a circumstance, the two entries will have the same PRIMARYID and the same DRUG_SEQ # 27. (or DSG_DRUG_SEQ # as it is called in the Therapy file - see below). 28. No therapy dates were reported for the concomitants; therefore, 29. they do not appear in the Drug Therapy file, which is excerpted as follows: 30. PRIMARYID DSG_DRUG_SEQ # START_DT END_DT 31. --- ---------- -------- ------ 32. 30781401 1 199704 19970613 33. 30781401 1 19970620 34. NOTE: The Drug Seq # is no longer a unique key as was the case in LAERS QDE. 35. The Drug Seq # simply shows the order of the DRUGNAME within a unique case. 36. Additionally, the fields labeled DRUG_SEQ, INDI_DRUG_SEQ, and DSG_DRUG_SEQ in the Drug, 37. Indication, and Therapy files, respectively, all serve the same purpose 38. of linking the data elements in each individual file together 39. with the appropriate drug listed in the case using the PRIMARYID. indi_pt: 1. "Preferred Term"-level medical terminology describing the Indication for use, 2. using the Medical Dictionary for Regulatory Activities (MedDRA). obs: 113,776 vars: 3 26 Mar 2015 16:12 size: 7,395,440 (_dta has notes) ------------------------------------------------------------------------------------------------------------------------------------- storage display value variable name type format label variable label ------------------------------------------------------------------------------------------------------------------------------------- primaryid long %12.0g * Unique number for identifying a FAERS report indi_drug_seq long %12.0g * Drug sequence number for identifying a drug for a Case indi_pt str57 %57s * 'Preferred Term'-level medical terminology describing the Indication for use * indicated variables have notes ------------------------------------------------------------------------------------------------------------------------------------- Sorted by: primaryid indi_drug_seq indi_pt