_dta: 1. by Jean Roth , jroth@nber.org , 18 Sep 2017 2. DRUGyyQq.TXT contains drug/biologic information for as many medications 3. as were reported for the event (1 or more 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. caseid: 1. Number for identifying a FAERS case (example. 3123456). 2. A case consists of one or more versions. 3. A follow-up version (that is, the newest/latest version received by FDA) 4. will have the same CASE number as the initial/oldest version. drug_seq: 1. Unique number for identifying a drug for a Case 2. To link to the THERyyQq.TXT data file, both the Case number (primary key) 3. and the DRUG_SEQ number (secondary key) are needed. 4. (For an explanation of the DRUG_SEQ number, including an example, please see Section E, End Note 2, below.) 5. DRUG_SEQ (Drug file, Therapy file, and Indications file). 6. The best way to explain the DRUG_SEQ (drug sequence number) is with an example. 7. This will also clarify the relationship between a Case, the drug(s) reported for that Case, 8. and the therapy date(s) reported for the drug(s). 9. Consider Case 3078140 version 1, received by the FDA on 12/31/97. 10. The PRIMARYID for this case is 30781401. 11. Like any Case, it appears once (and only once) in the Demographic file: 12. PRIMARYID 13. --- 14. 30781401 15. Four drugs were reported for this Case: Aricept was reported as suspect, and Estrogens, Prozac, and Synthroid as concomitant. 16. Primaryid 30781401 appears four times in the Drug file, with a different DRUG_SEQ for each drug: 17. PRIMARYID DRUG_SEQ DRUGNAME 18. --- -------- -------- 19. 30781401 1 Aricept 20. 30781401 2 Estrogens 21. 30781401 3 Prozac( Fluoxetine Hydrochloride 22. 30781401 4 Synthroid (Levothyroxine Sodium) 23. Dates of therapy for Aricept were reported as "4/97 to 6/13/97", and "6/20/97 (ongoing)." 24. Since the drug was started, stopped, then restarted, there are two entries in the Drug Therapy file. 25. In such a circumstance, the two entries will have the same PRIMARYID and the same DRUG_SEQ # 26. (or DSG_DRUG_SEQ # as it is called in the Therapy file - see below). 27. No therapy dates were reported for the concomitants; therefore, 28. they do not appear in the Drug Therapy file, which is excerpted as follows: 29. PRIMARYID DSG_DRUG_SEQ # START_DT END_DT 30. --- ---------- -------- ------ 31. 30781401 1 199704 19970613 32. 30781401 1 19970620 33. NOTE: The Drug Seq # is no longer a unique key as was the case in LAERS QDE. 34. The Drug Seq # simply shows the order of the DRUGNAME within a unique case. 35. Additionally, the fields labeled DRUG_SEQ, INDI_DRUG_SEQ, and DSG_DRUG_SEQ in the Drug, 36. Indication, and Therapy files, respectively, all serve the same purpose 37. of linking the data elements in each individual file together 38. with the appropriate drug listed in the case using the PRIMARYID. role_cod: 1. Code for drug's reported role in event.(See table below.) 2. CODE MEANING_TEXT 3. ---- ------------ 4. PS Primary Suspect Drug 5. SS Secondary Suspect Drug 6. C Concomitant 7. I Interacting drugname: 1. Name of medicinal product. 2. If a "Valid Trade Name" is populated for this Case, then DRUGNAME = Valid Trade Name; 3. if not, then DRUGNAME = "Verbatim" name, exactly as entered on the report. 4. For the great majority of reports, there is a "Valid Trade Name." val_vbm: 1. Code for source of DRUGNAME.(See table below.) 2. CODE MEANING_TEXT 3. ---- ------------ 4. 1 Validated trade name used 5. 2 Verbatim name used route: 1. The route of drug administration. dose_vbm: 1. Verbatim text for dose, frequency, and route, exactly as entered on report cum_dose_chr: 1. Cumulative dose to first reaction cum_dose_unit: 1. Cumulative dose to first reaction unit 2. CODE Meaning_Text 3. ---- ------------ 4. KG Kilogram(s) 5. GM Gram(s) 6. MG Milligram(s) 7. UG Microgram(s) (?g) 8. NG Nanogram(s) 9. PG Picogram(s) 10. MG/KG Milligram(s)/Kilogram 11. UG/KG Microgram(s)/Kilogram (?G/KG) 12. MG/M**2 Milligram(s)/Sq. Meter 13. UG/M**2 Microgram(s)/Sq. Meter (?G/M**2) 14. L Litre(s) 15. ML Millilitre(s) 16. UL Microlitre(s) (?L) 17. BQ Becquerel(s) 18. GBQ Gigabecquerel(s) 19. MBQ Megabecquerel(s) 20. KBQ Kilobecquerel(s) 21. CI Curie(s) 22. MCI Millicurie(s) 23. UCI Microcurie(s) (?CI) 24. NCI Nanocurie(s) 25. MOL Mole(s) 26. MMOL Mol Millimole(s) 27. MOL Micromole(s) 28. IU International Unit(s) 29. KIU International Unit*(1000s) 30. MIU International Unit*(1,000,000s) 31. IU/KG IU/Kilogram 32. MEQ Milliequivalent(s) 33. PCT Percent (%) 34. GTT Drop(s) 35. DF Dosage Form dechal: 1. Dechallenge code, indicating if reaction abated when drug therapy was stopped. (See table below.) 2. CODE MEANING_TEXT 3. ---- ------------ 4. Y Positive dechallenge 5. N Negative dechallenge 6. U Unknown 7. D Does not apply rechal: 1. Rechallenge code, indicating if reaction recurred when drug therapy was restarted. (See table below.) 2. CODE MEANING_TEXT 3. ---- ------------ 4. Y Positive rechallenge 5. N Negative rechallenge 6. U Unknown 7. D Does not apply lot_num: 1. Lot number of the drug. exp_dtstr: 1. Expiration date of the drug. (YYYYMMDD format) 2. If a complete date is not available, a partial date is provided, 3. See the NOTE on dates at the end of this section. nda_num: 1. NDA number (numeric only) dose_amt: 1. Amount of drug reported dose_unit: 1. "Unit of drug dose" dose_form: 1. Form of dose reported dose_freq: 1. Code for Frequency. (See table below.) 2. CODE Meaning_Text 3. ---- ------------ 4. 1X Once or one time 5. BID Twice a day 6. BIW Twice a week 7. HS At bedtime 8. PRN As needed 9. Q12H Every 12 hours 10. Q2H Every 2 hours 11. Q3H Every 3 hours 12. Q3W Every 3 weeks 13. Q4H Every 4 hours 14. Q5H Every 5 hours 15. Q6H Every 6 hours 16. Q8H Every 8 hours 17. QD Daily 18. QH Every hour 19. QID 4 times a day 20. QM Monthly 21. QOD Every other day 22. QOW Every other week 23. QW Every week 24. TID 3 times a day 25. TIW 3 times a week 26. UNK Unknown obs: 1,151,027 vars: 22 18 Sep 2017 12:22 size: 971,466,788 (_dta has notes) ---------------------------------------------------------------------------------------------------------------------------------------------------- storage display value variable name type format label variable label ---------------------------------------------------------------------------------------------------------------------------------------------------- primaryid long %12.0g * Unique number for identifying a FAERS report caseid long %12.0g * Number for identifying a FAERS case (example. 3123456) drug_seq int %8.0g * Unique number for identifying a drug for a Case role_cod str2 %9s * Code for drug's reported role in event drugname str178 %178s * Name of medicinal product prod_ai str300 %300s Product Active Ingredient val_vbm byte %8.0g * Code for source of DRUGNAME route str37 %37s * The route of drug administration dose_vbm str152 %152s * Verbatim text for dose, frequency, and route, exactly as entered on report cum_dose_chr float %9.0g * Cumulative dose to first reaction cum_dose_unit str5 %9s * Cumulative dose to first reaction unit dechal str1 %9s * Dechallenge code, indicating if reaction abated when drug therapy was stopped rechal str1 %9s * Rechallenge code, indicating if reaction recurred when drug therapy restarted lot_num str49 %49s * Lot number of the drug exp_dt float %td Expiration date of the drug.Multiple dates possible. exp_dtstr str17 %17s * Expiration date of the drug.Multiple dates possible. exp_dt_mult float %9.0g Multiple Expiration Dates nda_num double %10.0g * NDA number (numeric only) dose_amt float %9.0g * Amount of drug reported dose_unit str7 %9s * Unit of drug dose dose_form str50 %50s * Form of dose reported dose_freq str10 %10s * Code for Frequency * indicated variables have notes ---------------------------------------------------------------------------------------------------------------------------------------------------- Sorted by: primaryid drug_seq