The Safety Rates Drug Report

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Drug     Injury     Quarter    

Person who experienced the adverse event (patient)

Event ID CASE I F COD FOLL SEQ IMAGE EVENT DT MFR DT FDA DT REPT COD MFR NUM MFR SNDR AGE AGE COD GNDR COD E SUB WT WT COD REPT DT OCCP COD DEATH DT TO MFR CONFID REPORTER COUNTRY
6140958 6965802 I 6140958-6 20090225 20090316 20090331 EXP A-CH2009-24480 ACTELION PHARMACEUTICALS US, INC. 43 YR F N 53 KG 20090330 MD 20090309 TAIWAN, PROVINCE OF CHINA

Drug(s) used by person

Event ID DRUG SEQ ROLE COD DRUGNAME VAL VBM ROUTE DOSE VBM DECHAL RECHAL LOT NUM EXP DT NDA NUM
6140958 1011367866 PS TRACLEER 1 ORAL 125 MG, BID, ORAL; 62.5 MG, BID, D D EP039P201 20100301 21290
6140958 1011408788 C WARFARIN SODIUM 1
6140958 1011408789 C LEVOCETIRIZINE (LEVOCETERIZINE) 2

Indications of drugs used

Event ID DRUG SEQ INDI PT
6140958 1011367866 PULMONARY ARTERIAL HYPERTENSION

Outcome of event

Event ID OUTC COD
6140958 DE
6140958 HO
6140958 OT

Reactions reported

Event ID PT
6140958 ALANINE AMINOTRANSFERASE INCREASED
6140958 ANAESTHETIC COMPLICATION
6140958 ASPARTATE AMINOTRANSFERASE INCREASED
6140958 BLOOD BILIRUBIN INCREASED
6140958 ENDOMETRIAL DISORDER

Reporting Sources (this data is often not reported and may therefore be missing here)

Event ID RPSR COD
6140958 FGN
6140958 HP
6140958 OTH

Therapies reported

Event ID DRUG SEQ START DT END DT DUR DUR COD
6140958 1011367866 20070712 20070811
6140958 1011367866 20070812 20090201