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
127082981 12708298 1 I 20160826 20160901 20160901 EXP NL-MYLANLABS-2016M1037070 MYLAN SCHERPBIER HJ, TERPSTRA V, PAJKRT D, PUTHAKANIT T, ANANWORANICH J, FOSTER C, ET AL. NONCIRRHOTIC PORTAL HYPERTENSION IN PERINATALLY HIV-INFECTED ADOLESCENTS TREATED WITH DIDANOSINE-CONTAINING ANTIRETROVIRAL REGIMENS IN CHILDHOOD. PEDIATR-INFECT-DIS-J 2016;35(8):E248-E252. 0.00 Y 0.00000 20160901 MD NL NL

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
127082981 12708298 1 PS DIDANOSINE. DIDANOSINE 1 Unknown Y U 90788
127082981 12708298 2 C ZIDOVUDINE. ZIDOVUDINE 1 Unknown U 0
127082981 12708298 3 C STAVUDINE. STAVUDINE 1 Unknown U 0
127082981 12708298 4 C LAMIVUDINE. LAMIVUDINE 1 Unknown U 0
127082981 12708298 5 C ABACAVIR. ABACAVIR 1 Unknown U 0
127082981 12708298 6 C EFAVIRENZ EFAVIRENZ 1 Unknown U 0
127082981 12708298 7 C NELFINAVIR NELFINAVIR 1 Unknown U 0

Indications of drugs used

Event ID CASEID INDI DRUG SEQ INDI PT
127082981 12708298 1 Perinatal HIV infection
127082981 12708298 2 Perinatal HIV infection
127082981 12708298 3 Perinatal HIV infection
127082981 12708298 4 Perinatal HIV infection
127082981 12708298 5 Perinatal HIV infection
127082981 12708298 6 Perinatal HIV infection
127082981 12708298 7 Perinatal HIV infection

Outcome of event

Event ID CASEID OUTC COD
127082981 12708298 OT

Reactions reported

Event ID CASEID DRUG REC ACT PT
127082981 12708298 Gastric varices haemorrhage
127082981 12708298 Non-cirrhotic portal hypertension

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

no results found

Therapies reported

no results found