The Safety Rates Drug Report

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Drug     Injury     Quarter    

Person who experienced the adverse event (patient)

Event ID CASEID CASEVERSION I F COD EVENT DT MFR DT INIT FDA DT FDA DT REPT COD AUTH NUM MFR NUM MFR SNDR LIT REF AGE AGE COD AGE GRP GNDR COD E SUB WT WT COD REPT DT TO MFR OCCP COD REPORTER COUNTRY OCCR COUNTRY
117918422 11791842 2 F 201505 20160813 20151201 20160823 EXP US-BAYER-2014-064680 BAYER 26.00 YR A F Y 68.27000 KG 20160823 OT US US

Drug(s) used by person

Event ID CASEID DRUG SEQ ROLE COD DRUGNAME PROD AI VAL VBM ROUTE DOSE VBM CUM DOSE CHR CUM DOSE UNIT DECHAL RECHAL LOT NUM EXP DT NDA NUM DOSE AMT DOSE UNIT DOSE FORM DOSE FREQ
117918422 11791842 1 PS ADEMPAS RIOCIGUAT 1 UNK 204819
117918422 11791842 2 SS ADEMPAS RIOCIGUAT 1 Oral 1.5 MG, TID BXGGF91A 204819 1.5 MG TID
117918422 11791842 3 SS ADEMPAS RIOCIGUAT 1 Oral 1 MG, TID BXGGF81A 204819 1 MG TID
117918422 11791842 4 SS ADEMPAS RIOCIGUAT 1 Oral 1 MG, TID BXH0L11 204819 1 MG TID
117918422 11791842 5 SS ADEMPAS RIOCIGUAT 1 Oral 1 MG, TID (LAST SHIPPED 03-AUG-2015) BXH0L11 204819 1 MG TID
117918422 11791842 6 SS ADEMPAS RIOCIGUAT 1 1 MG, TID (LAST SHIPPED ON 22-JUL-2016) BXH94J1 204819 1 MG TID
117918422 11791842 7 SS FLOLAN EPOPROSTENOL SODIUM 1 0
117918422 11791842 8 C OPSUMIT MACITENTAN 1 0
117918422 11791842 9 C COUMADIN WARFARIN SODIUM 1 0
117918422 11791842 10 C FLOLAN [EPOPROSTENOL SODIUM] 2 0
117918422 11791842 11 C IUD NOS COPPER OR LEVONORGESTREL 1 0
117918422 11791842 12 C REMODULIN TREPROSTINIL 1 0

Indications of drugs used

Event ID CASEID INDI DRUG SEQ INDI PT
117918422 11791842 1 Pulmonary arterial hypertension
117918422 11791842 2 Pulmonary arterial hypertension
117918422 11791842 3 Pulmonary arterial hypertension
117918422 11791842 4 Pulmonary arterial hypertension
117918422 11791842 5 Pulmonary arterial hypertension
117918422 11791842 6 Pulmonary arterial hypertension

Outcome of event

Event ID CASEID OUTC COD
117918422 11791842 OT
117918422 11791842 HO

Reactions reported

Event ID CASEID DRUG REC ACT PT
117918422 11791842 Abdominal discomfort
117918422 11791842 Catheter site infection
117918422 11791842 Device connection issue
117918422 11791842 Device leakage
117918422 11791842 Diarrhoea
117918422 11791842 Dizziness
117918422 11791842 Drug dose omission
117918422 11791842 Headache
117918422 11791842 Hospitalisation
117918422 11791842 Inappropriate schedule of drug administration
117918422 11791842 Nasal congestion
117918422 11791842 Nasopharyngitis
117918422 11791842 Nausea
117918422 11791842 Palpitations
117918422 11791842 Tooth disorder

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

no results found

Therapies reported

Event ID CASEID DSG DRUG SEQ START DT END DT DUR DUR COD
117918422 11791842 1 20140210 0
117918422 11791842 2 20140213 0