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
124629922 12462992 2 F 201604 20160617 20160614 20160831 PER US-JNJFOC-20160505791 JANSSEN 13.19 YR C M Y 45.36000 KG 20160831 CN 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
124629922 12462992 1 SS TOPAMAX TOPIRAMATE 1 Oral Y U 15KG783;15KG783;16BG253 +MORE 0 100 MG TABLETS BID
124629922 12462992 2 PS TOPAMAX TOPIRAMATE 1 Oral Y U 15KG783;15KG783;16BG253 +MORE 20505 200 MG TABLETS BID

Indications of drugs used

Event ID CASEID INDI DRUG SEQ INDI PT
124629922 12462992 1 Seizure
124629922 12462992 2 Seizure

Outcome of event

Event ID CASEID OUTC COD
124629922 12462992 OT

Reactions reported

Event ID CASEID DRUG REC ACT PT
124629922 12462992 Diarrhoea
124629922 12462992 Fall
124629922 12462992 Hypersomnia
124629922 12462992 Product colour issue
124629922 12462992 Respiratory disorder
124629922 12462992 Seizure
124629922 12462992 Syncope
124629922 12462992 Weight decreased

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

no results found

Therapies reported

no results found