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
126993361 12699336 1 I 20160816 20160830 20160830 EXP IT-CORDEN PHARMA LATINA S.P.A.-IT-2016COR000203 CORDEN PAGANO L, STAMOULI M, TUMBARELLO M, VERGA L, CANDONI A, CATTANEO C, ET AL. RISK OF INVASIVE FUNGAL INFECTION IN PATIENTS AFFECTED BY ACUTE PROMYELOCYTIC LEUKAEMIA. A REPORT BY THE SEIFEM-D REGISTRY. BR J HAEMATOL. 2015;170(3):434-439;DOI: 10.1111/BJH.13308 25.00 YR F Y 0.00000 20160830 OT IT IT

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
126993361 12699336 1 PS ETOPOSIDE. ETOPOSIDE 1 UNK U 18768
126993361 12699336 2 SS MITOXANTRONE MITOXANTRONE HYDROCHLORIDE 1 UNK U 0
126993361 12699336 3 SS ALL-TRANS RETINOIC ACID TRETINOIN 1 UNK, 2ND COURSE 0
126993361 12699336 4 SS IDARUBICIN IDARUBICIN 1 UNK U 0

Indications of drugs used

Event ID CASEID INDI DRUG SEQ INDI PT
126993361 12699336 1 Acute promyelocytic leukaemia
126993361 12699336 2 Acute promyelocytic leukaemia
126993361 12699336 3 Acute promyelocytic leukaemia
126993361 12699336 4 Acute promyelocytic leukaemia

Outcome of event

Event ID CASEID OUTC COD
126993361 12699336 OT

Reactions reported

Event ID CASEID DRUG REC ACT PT
126993361 12699336 Chest pain
126993361 12699336 Lower respiratory tract infection fungal
126993361 12699336 Pyrexia

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

no results found

Therapies reported

no results found