GLOBAL MAP DATA DICTIONARY #120.85 -- ADVERSE REACTION REPORTING FILE 3/24/25 PAGE 1 STORED IN ^GMR(120.85, *** NO DATA STORED YET *** SITE: WWW.BMIRWIN.COM UCI: VISTA,VISTA (VERSION 4.0) ----------------------------------------------------------------------------------------------------------------------------------- This file contains all the data for an Observed Drug reaction. CROSS REFERENCED BY: DATE REPORTED(ARDT), DATE/TIME OF EVENT(B), RELATED REACTION(C), PATIENT(D) INDEXED BY: DATE/TIME OF EVENT & PATIENT & RELATED REACTION & OBSERVER & DATE REPORTED & REPORTING USER & QUESTION #1 & QUESTION #2 & QUESTION #3 & QUESTION #4 & QUESTION #5 & NO. DAY HOSPITALIZED & QUESTION #6 & QUESTION #7 & QUESTION #8 & QUESTION #9 & QUESTION #10 & SEVERITY & DATE MD NOTIFIED & FDA QUESTION #1 & FDA QUESTION #2 & FDA QUESTION #3 & FDA QUESTION #4 & FDA QUESTION #5 & DATE REPORTED TO FDA & DATE OF PATIENT CONSENT TO MFR & DATE SENT TO MFR & DATE SENT TO VAERS & P&T ACTION FDA REPORT & P&T ACTION MFR REPORT & REPORTER NAME & REPORTER ADDRESS1 & REPORTER ADDRESS2 & REPORTER ADDRESS3 & REPORTER CITY & REPORTER STATE & REPORTER ZIP & REPORTER PHONE & RPT QUESTION #1 & RPT QUESTION #2 & OCCUPATION & MANUFACTURER NAME & MFR ADDRESS #1 & MFR ADDRESS #2 & MFR ADDRESS #3 & MFR CITY & MFR STATE & MFR ZIP & IND/NDA # FOR SUPPORT DRUG & MFR CONTROL # & DATE RECEIVED BY MFR & 15 DAY REPORT & REPORT TYPE (AHDR) ^GMR(120.85,D0,0)= (#.01) DATE/TIME OF EVENT [1D] ^ (#.02) PATIENT [2P:2] ^ (#5) QUESTION #1 [3S] ^ (#6) QUESTION #2 [4S] ^ (#7) ==>QUESTION #3 [5S] ^ (#8) QUESTION #4 [6S] ^ (#9) QUESTION #5 [7S] ^ (#9.1) NO. DAY HOSPITALIZED [8N] ^ (#10) ==>QUESTION #6 [9S] ^ (#11) QUESTION #7 [10S] ^ (#12) QUESTION #8 [11S] ^ (#22) DATE MD NOTIFIED [12D] ^ (#.5) ==>OBSERVER [13P:200] ^ (#14.5) SEVERITY [14S] ^ (#.03) RELATED REACTION [15P:120.8] ^ (#12.1) QUESTION #9 [16S] ==>^ (#12.2) QUESTION #10 [17S] ^ (#1.1) DATE REPORTED [18D] ^ (#1.2) REPORTING USER [19P:200] ^ ^GMR(120.85,D0,2,0)=^120.8502P^^ (#2) REACTIONS ^GMR(120.85,D0,2,D1,0)= (#.01) REACTIONS [1P:120.83] ^ (#1) OTHER REACTION [2F] ^ (#2) ENTERED BY [3P:200] ^ ^GMR(120.85,D0,3,0)=^120.8503^^ (#3) SUSPECTED AGENT ^GMR(120.85,D0,3,D1,0)= (#.01) SUSPECTED AGENT [1F] ^ (#1) DAILY DOSE [2F] ^ (#2) ROUTE OF ADMINISTRATION [3F] ^ (#3) INDICATIONS ==>FOR USE [4F] ^ ^ ^ (#7) MANUFACTURER [7F] ^ (#8) LOT # [8F] ^ (#9) NUMBER OF PREVIOUS DOSES [9N] ^ ==>(#10) LAST FILL DT [10D] ^ ^GMR(120.85,D0,3,D1,1)= (#4) START DATE OF ADMINISTRATION [1D] ^ (#5) STOP DATE OF ADMINISTRATION [2D] ^ (#10.1) EXPIRATION DATE ==>[3D] ^ (#10.2) NDC # [4F] ^ (#1.5) SIG [5F] ^ ^GMR(120.85,D0,3,D1,LIKE)= (#11) LIKE QUESTION #1 [1S] ^ (#12) LIKE QUESTION #2 [2S] ^ (#13) LIKE QUESTION #3 [3S] ^ (#14) LIKE ==>QUESTION #4 [4S] ^ (#15) LIKE QUESTION #5 [5S] ^ (#16) LIKE QUESTION #6 [6S] ^ (#17) LIKELIHOOD [7S] ^ ^GMR(120.85,D0,4,0)=^120.8504^^ (#4) RELEVANT TEST/LAB DATA ^GMR(120.85,D0,4,D1,0)= (#.01) TEST [1F] ^ (#1) RESULTS [2F] ^ (#2) COLLECTION D/T [3D] ^ ^GMR(120.85,D0,13,0)=^120.8513^^ (#13) CONCOMITANT DRUGS ^GMR(120.85,D0,13,D1,0)= (#.01) CONCOMITANT DRUGS [1F] ^ (#1) START DATE OF ADMINISTRATION [2D] ^ (#2) STOP DATE OF ==>ADMINISTRATION [3D] ^ (#3) LAST FILL DT [4D] ^ (#4) SIG [5F] ^ ^GMR(120.85,D0,14,0)=^120.8514^^ (#14) OTHER RELATED HISTORY ^GMR(120.85,D0,14,D1,0)= (#.01) OTHER RELATED HISTORY [1W] ^ ^GMR(120.85,D0,63,0)=^120.8563S^^ (#63) REPORT SOURCE ^GMR(120.85,D0,63,D1,0)= (#.01) SOURCE [1S] ^ ^GMR(120.85,D0,MFR1)= (#53) MANUFACTURER NAME [1F] ^ (#54) MFR ADDRESS #1 [2F] ^ (#55) MFR ADDRESS #2 [3F] ^ (#56) MFR ADDRESS #3 ==>[4F] ^ (#57) MFR CITY [5F] ^ (#58) MFR STATE [6P:5] ^ (#59) MFR ZIP [7F] ^ ^GMR(120.85,D0,MFR2)= (#60) IND/NDA # FOR SUPPORT DRUG [1F] ^ (#61) MFR CONTROL # [2F] ^ (#62) DATE RECEIVED BY MFR [3D] ^ (#64) ==>15 DAY REPORT [4S] ^ (#65) REPORT TYPE [5S] ^ ^GMR(120.85,D0,PTC1)= (#23) FDA QUESTION #1 [1S] ^ (#24) FDA QUESTION #2 [2S] ^ (#25) FDA QUESTION #3 [3S] ^ (#26) FDA QUESTION ==>#4 [4S] ^ (#27) DATE REPORTED TO FDA [5D] ^ (#28) DATE OF PATIENT CONSENT TO MFR [6D] ^ (#29) DATE SENT TO ==>MFR [7D] ^ (#30) *DATE SENT TO RCPM [8D] ^ (#31) DATE SENT TO VAERS [9D] ^ (#31.1) P&T ACTION FDA REPORT ==>[10S] ^ (#31.2) P&T ACTION MFR REPORT [11S] ^ (#31.3) *P&T ACTION RCPM REPORT [12S] ^ (#26.1) FDA QUESTION ==>#5 [13S] ^ ^GMR(120.85,D0,PTC2,0)=^120.85315D^^ (#31.5) P&T ADDENDUM ^GMR(120.85,D0,PTC2,D1,0)= (#.01) DATE/TIME ENTERED [1D] ^ ^GMR(120.85,D0,PTC2,D1,1,0)=^120.853151^^ (#1) ADDENDUM ^GMR(120.85,D0,PTC2,D1,1,D2,0)= (#.01) ADDENDUM [1W] ^ ^GMR(120.85,D0,RPT)= (#43) REPORTER NAME [1F] ^ (#44) REPORTER ADDRESS1 [2F] ^ (#45) REPORTER ADDRESS2 [3F] ^ (#46) REPORTER ==>ADDRESS3 [4F] ^ (#47) REPORTER CITY [5F] ^ (#48) REPORTER STATE [6P:5] ^ (#49) REPORTER ZIP [7F] ^ (#50) ==>REPORTER PHONE [8F] ^ (#51) RPT QUESTION #1 [9S] ^ (#52) RPT QUESTION #2 [10S] ^ (#52.1) OCCUPATION [11F] ^ INPUT TEMPLATE(S): PRINT TEMPLATE(S): SORT TEMPLATE(S): FORM(S)/BLOCK(S):