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
119153662 11915366 2 F 2001 20160829 20160114 20160902 EXP FR-BRISTOL-MYERS SQUIBB COMPANY-11527082 BRISTOL MYERS SQUIBB 0.00 YR F Y 1.00000 KG 20160902 OT FR FR

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
119153662 11915366 1 PS ZERIT STAVUDINE 1 Transplacental EXPOSURE BEGAN AT CONCEPTION. U 20412 60 MG CAPSULE, HARD QD
119153662 11915366 2 SS VIDEX DIDANOSINE 1 Transplacental EXPOSURE BEGAN AT CONCEPTION. U 0 250 MG QD
119153662 11915366 3 SS INVIRASE SAQUINAVIR MESYLATE 1 Transplacental EXPOSURE BEGAN AT CONCEPTION. U 0 400 MG QD
119153662 11915366 4 SS NORVIR RITONAVIR 1 Transplacental EXPOSURE BEGAN AT CONCEPTION. U 0 600 MG QD
119153662 11915366 5 C BACTRIM SULFAMETHOXAZOLETRIMETHOPRIM 1 Transplacental EXPOSURE DURING GESTATION. U 0

Indications of drugs used

Event ID CASEID INDI DRUG SEQ INDI PT
119153662 11915366 1 Product used for unknown indication
119153662 11915366 2 Product used for unknown indication
119153662 11915366 3 Product used for unknown indication
119153662 11915366 4 Product used for unknown indication
119153662 11915366 5 Product used for unknown indication

Outcome of event

Event ID CASEID OUTC COD
119153662 11915366 CA
119153662 11915366 DE
119153662 11915366 LT
119153662 11915366 OT

Reactions reported

Event ID CASEID DRUG REC ACT PT
119153662 11915366 Atrioventricular septal defect
119153662 11915366 Death neonatal
119153662 11915366 Foetal exposure during pregnancy
119153662 11915366 Heart disease congenital
119153662 11915366 Premature baby
119153662 11915366 Trisomy 18

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
119153662 11915366 1 20010825 0
119153662 11915366 2 20010825 0
119153662 11915366 3 20010825 0
119153662 11915366 4 20010825 0