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7.12 PRODUCT EXPERIENCE - EXAMPLE MESSAGES

The RXE segments in this message include a proposed change in RXE to include an element to transmit the indication as a coded entity (CE).

MSH|^-&|...
EVN|...
PID|1|||A^A^A||19230616|F||||||||||||||||19950710|Y<cr>
PES|^Eli Lilly and Company^||Lilly Corporate Center^Indianapolis^IN^46285|| GB95070448A|0|||19950704|19950710|10D<cr>
PEO||^Awaiting results of autopsy^|19950704||||^^^^^GB||S|N|D^H^O||Patient admitted via casualty with increased shortness of breath and left sided chest pain on 04 JUL 95 for assessment.^11-JUL-95 Patient admitted 09-JUL-95 at 11:30 PM with an 18 hour history of diarrhoea followed by collapse. On admission, patient was exhausted and dehydrated.  She had a rash on both breasts and abdomen. Patient found to have deteriorating renal function.  Patient commenced IV fluid, however patient was found dead on 10-JUL-95 morning.  Query vomited and aspirated. Post mortem requested. Events possibly related to study drug.<cr>
PCR|xxxxx^Wonder Drug 1^ATC|N|antineoplastic|||||||^NON SMALL CELL LUNG CANCER<cr>
RXE|1^^^06/29/95^07/10/95|xxxxx^Wonder Drug 1^ATC||||||||||||||||||||M1|3||NON SMALL CELL LUNG CANCER<cr>
RXR|PO<cr>
RXE|1|NO2AA^DIHYDROCODEINE^ATC||||||||||||||||||||D1|120|MG^MG^L|PAIN<cr>
RXR|PO<cr>
RXE|1^^^06/27/95^|GO3AC^MEGESTROL^ATC||||||||||||||||||||D1|320|MG^MG^L|DECREASED APPETITE<cr>
RXR|PO<cr>
RXE|1|AO2BC^OMEPRAZOLE^ATC||||||||||||||||||||D1|20|MG^MG^L|PAST HX<cr>
RXR|PO<cr>
RXE|1|AO7EC^SULPHASALAZINE^ATC||||||||||||||||||||D1|1000|MG^MG^L|RHEUMAT<cr>
RXR|PO<cr>
RXE|1^^^06/27/95^|A11GA^ASCORBIC ACID^ATC||||||||||||||||||||D1|1|TAB^TAB^L|DECREASED APPETITE<cr>
RXR|PO<cr>
RXE|1^^^06/27/95^|A11DA^THIAMINE^ATC||||||||||||||||||||D1|1|TAB^TAB^L|DECREASED APPETITE<cr>
RXR|PO<cr>
RXE|1^^^06/29/95^|AO3FA^METOCLOPRAMIDE^ATC||||||||||||||||||||D1|60|MG^MG^L|NAUSEA<cr>
RXR|PO<cr>
RXE|1|BO3A^IRON^ATC||||||||||||||||||||D1|600|MG^MG^L|ANEMIA<cr>
RXR|PO<cr>
PRB|AD|19950704|705^DYSPNEA^MEDR<cr>
PRB|AD|19950710|20143^DEATH^MEDR<cr>
PRB|AD|19950704|18330^CHEST PAIN^MEDR<cr>
PRB|AD|19950709|21197^DIARRHEA^MEDR<cr>
PRB|AD|19950709|6432^SYNCOPE^MEDR<cr>
PRB|AD|19950709|4966^DEHYDRATION^MEDR<cr>
PRB|AD|19950709|20544^KIDNEY FUNCTION ABNORMAL^MEDR<cr>
OBX|1|CE|804-5^lEUKOCYTES^LN||2300|10*3/ml||||||19940704<cr>
OBX|2|CE|770-8^NEUTROPHILS/100 LEUKOCYTES^LN||1.9|%||||||19950704<cr>
OBX|2|CE|6299-2^UREA NITROGEN^LN||22.3|mg%||||||19950709<cr>
OBX|2|CE|2160-0^CREATININE^LN||247|mmole||||||19950709<cr>
NTE|Additional details must be obtained from the affiliate in order to assess causality. A three day alert phone call was made to the FDA on 12-JUL-95<cr>

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