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
4390001 4193104 I 4390001-4 20040614 20040616 20040630 EXP A-CH2004-06615 ACTELION PHARMACEUTICALS US, INC 71 YR F N 50 KG 20040629

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
4390001 1004988339 PS TRACLEER 1 ORAL 62.5 MG, BID, ORAL Y D 21290
4390001 1005006430 C RIFAMPICIN 1
4390001 1005006431 C PYOSTACINE (PRISTINAMYCIN) 2
4390001 1005006433 C VANCOMYCIN 1
4390001 1005006434 C ACETAMINOPHEN 1
4390001 1005006435 C OMEPRAZOLE 1
4390001 1005006436 C CALCIDOSE (CALCIUM CARBONATE) 2
4390001 1005006437 C PREDNISONE TAB 1
4390001 1005006438 C PRAXILENE (NAFIDROFURYL OXALATE) 2

Indications of drugs used

Event ID DRUG SEQ INDI PT
4390001 1004988339 PULMONARY HYPERTENSION

Outcome of event

Event ID OUTC COD
4390001 OT

Reactions reported

Event ID PT
4390001 ALANINE AMINOTRANSFERASE INCREASED
4390001 ASPARTATE AMINOTRANSFERASE INCREASED
4390001 TRANSAMINASES INCREASED

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

Event ID RPSR COD
4390001 FGN
4390001 HP
4390001 OTH
4390001 SDY

Therapies reported

Event ID DRUG SEQ START DT END DT DUR DUR COD
4390001 1004988339 20040517 20040614