_dta: 1. by Jean Roth , jroth@nber.org , 26 Mar 2015 2. DEMOyyQq.TXT contains patient demographic and administrative information, a single record for each event report. 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. i_f_code: 1. Code for initial or follow-up status of report, as reported by manufacturer. 2. CODE MEANING_TEXT 3. ---- ------------ 4. I Initial 5. F Follow-up foll_seq: 1. The sequence number of a followup report, as reported by 2. manufacturer. For initial reports, there will be no data for 3. this field. (A small number of reports may have "bad" data 4. for this number, such as alphabetic or special characters.) 5. (See End Note 2.) 6. 2 CASE, I_F_COD, and FOLL_SEQ (Demographic file). In AERS, a "case" 7. consists of one or more reports (ISRs). If correctly linked, a followup 8. report will have the same CASE number as the initial report (but a 9. different ISR number). It should be kept in mind that the AERS system's determination 10. of what is a follow-up will usually, but not always, 11. agree with how a manufacturer shows follow-up status on a report. 12. The I_F_COD code and the FOLL_SEQ number are basically verbatim data 13. as given by the manufacture; in contrast, the case number is 14. based on the AERS system's independent determination of what it 15. considers linked reports. For initial reports, there will be no 16. FOLL_SEQ number. image: 1. notes image : Identifier for an AERS report image. Character field consisting of 2. notes image : the ISR number, a dash, and a check digit or letter. 3. notes image : (ex: 3123456-X) See End Note 3. 4. 3 IMAGE (Demographic file). The Image number is the identifying 5. number that should be used by anyone requesting sanitized hard copies 6. of reports through the FOIA. Address: Food and Drug Administration, 7. Freedom of Information Staff (HFI-35), 5600 Fishers Lane (Rm 12A-16), 8. Rockville, MD, 20857, USA. Website: www.fda.gov/foi event_dt: 1. Date the adverse event occurred or began. (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. event_dt_num: 1. Date the adverse event occurred or began. (YYYYMMDD format) 2. YYYY-onlys are converted to midpoint of year: YYYY0702 3. YYYYMM-onlys are converted to midpoint of month: YYYYMM15 mfr_dt: 1. Date manufacturer first received initial information. 2. In subsequent versions of a case, the latest manufacturer received date will be provided (YYYYMMDD format). 3. If a complete date is not available, a partial date will be provided. 4. See the NOTE on dates at the end of this section. mfr_dt_num: 1. Date manufacturer first received initial information. 2. YYYY-onlys are converted to midpoint of year: YYYY0702 3. YYYYMM-onlys are converted to midpoint of month: YYYYMM15 fda_dt: 1. Date FDA received report. (YYYYMMDD format) fda_dt_num: 1. Date FDA received report. (YYYYMMDD) rept_cod: 1. Code for the type of report submitted. (See table below.) 2. Also, see Section E, End Note 1, below. 3. CODE MEANING_TEXT 4. ---- --------------- 5. EXP Expedited (15-Day) 6. PER Periodic 7. DIR Direct 8. Expedited (15-day) and Periodic reports are from manufacturers; 9. "Direct" reports are voluntarily submitted to the FDA by non-manufacturers. mfr_num: 1. Manufacturer's unique report identifier. mfr_sndr: 1. Coded name of manufacturer sending report; 2. if not found, then verbatim name of organization sending report. age: 1. Numeric value of patient's age at event. age_cod: 1. Unit abbreviation for patient's age. (See table below.) 2. CODE MEANING_TEXT 3. ---- ------------ 4. DEC DECADE 5. YR YEAR 6. MON MONTH 7. WK WEEK 8. DY DAY 9. HR HOUR sex: 1. Code for patient's sex. (See table below.) 2. CODE MEANING_TEXT 3. ---- ------------ 4. UNK Unknown 5. M Male 6. F Female 7. NS Not Specified e_sub: 1. Whether (Y/N) this report was submitted under the electronic submissions procedure for manufacturers. wt: 1. Numeric value of patient's weight. wt_cod: 1. Unit abbreviation for patient's weight. (See table below.) 2. CODE MEANING_TEXT 3. ---- ------------ 4. KG Kilograms 5. LBS Pounds 6. GMS Grams rept_dt: 1. Date report was sent (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. occp_cod: 1. Abbreviation for the reporter's type of occupation in the latest version of a case. 2. CODE MEANING_TEXT 3. ---- ------------ 4. MD Physician 5. PH Pharmacist 6. OT Other health-professional 7. LW Lawyer 8. CN Consumer to_mfr: 1. Whether (Y/N) voluntary reporter also notified manufacturer (blank for manufacturer reports). confid: 1. Whether or not (Y/N) voluntary reporter stated that his 2. identity should not be disclosed to the product manufac- 3. turer (blank for manufacturer reports). reporter_country: 1. The country of the reporter in the latest version of a case: 2. NOTE: Country codes are available per the links below. 3. http://estri.ich.org/icsr/ICH_ICSR_Specification_V2-3.pdf 4. http://www.iso.org/iso/home/standards/country_codes/iso-3166-1_decoding_table.htm obs: 83,977 vars: 30 26 Mar 2015 16:01 size: 21,498,112 (_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) i_f_code str1 %9s * Code for initial or follow-up status of report, as reported i_f_code_num float %11.0g i_f_code_num Code for initial or follow-up status of report, as reported foll_seq str2 %9s * The sequence number of a followup report image str9 %9s * Identifier for an AERS report image event_dt long %12.0g * Date the adverse event occurred or began event_dt_num float %td * Date the adverse event occurred or began mfr_dt long %12.0g * Date manufacturer first received initial information mfr_dt_num float %td * Date manufacturer first received initial information fda_dt long %12.0g * Date FDA received report fda_dt_num float %td * Date FDA received report rept_cod str3 %9s * Code for the type of report submitted rept_cod_num float %22.0g rept_cod_num mfr_num str61 %61s * Manufacturer's unique report identifier mfr_sndr str60 %60s * Coded name of manufacturer sending report age float %9.0g * Numeric value of patient's age at event age_cod str3 %9s * Unit abbreviation for patient's age sex str3 %9s * Code for patient's sex e_sub str1 %9s * (Y/N) report was submitted under the electronic submissions procedure for manufa wt float %9.0g * Numeric Value of Patient's Weight wt_cod str3 %9s * Unit abbreviation for patient's weight rept_dt long %10.0g * Date report was sent (YYYYMMDD format) rept_dt_num float %td Date report was sent (YYYYMMDD format) occp_cod str2 %9s * Abbreviation for the reporter's type of occupation in the latest version of a ca death_dt long %12.0g DEATH_DT to_mfr str1 %9s * Whether (Y/N) voluntary reporter also notified manufacturer (blank for manufactu confid str1 %9s * Whether or not (Y/N) voluntary reporter disclosed identity reporter_country str42 %42s * The country of the reporter in the latest version of a case occp_cod_num float %28.0g occp_cod_num * indicated variables have notes ------------------------------------------------------------------------------------------------------------------------------------- Sorted by: primaryid i_f_code_num: 70 F Follow-up 72 I Initial rept_cod_num: 687382 DIR Direct 698880 EXP Expedited (15-Day) 806982 PER Periodic occp_cod_num: 6778 CN Consumer 7687 LW Lawyer 7768 MD Physician 7984 OT Other health-professional 8072 PH Pharmacist 8278 RN Registered Nurse 8365 SALES