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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
127178341 | 12717834 | 1 | I | 20150923 | 20160125 | 20160906 | 20160906 | PER | US-AMNEAL PHARMACEUTICALS-2016AMN00059 | AMNEAL | 73.86 | YR | M | Y | 0.00000 | 20160906 | 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
127178341 | 12717834 | 1 | PS | FLECAINIDE ACETATE. | FLECAINIDE ACETATE | 1 | 50 MG, 2X/DAY | 75442 | 50 | MG | TABLET | QD | |||||||
127178341 | 12717834 | 2 | SS | FLECAINIDE ACETATE. | FLECAINIDE ACETATE | 1 | 50 MG, 2X/DAY | 75442 | 50 | MG | TABLET | BID |
Indications of drugs used
Event ID | CASEID | INDI DRUG SEQ | INDI PT |
---|---|---|---|
127178341 | 12717834 | 1 | Arrhythmia |
Outcome of event
no results found |
Reactions reported
Event ID | CASEID | DRUG REC ACT | PT |
---|---|---|---|
127178341 | 12717834 | Adverse event | |
127178341 | 12717834 | Condition aggravated | |
127178341 | 12717834 | Drug ineffective | |
127178341 | 12717834 | Product formulation issue |
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 |
---|---|---|---|---|---|---|
127178341 | 12717834 | 1 | 20150923 | 0 |