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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127045711 | 12704571 | 1 | I | 20160411 | 20160831 | 20160831 | PER | US-SA-2016SA074473 | AVENTIS | 45.00 | YR | A | F | Y | 0.00000 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127045711 | 12704571 | 1 | PS | AVAPRO | IRBESARTAN | 1 | Unknown | Y | HB038 | 20757 | 300 | MG | FILM-COATED TABLET | QD | |||||
| 127045711 | 12704571 | 2 | SS | AVAPRO | IRBESARTAN | 1 | Unknown | Y | HB038 | 20757 | 300 | MG | FILM-COATED TABLET | ||||||
| 127045711 | 12704571 | 3 | SS | AVAPRO | IRBESARTAN | 1 | Unknown | Y | HB038 | 20757 | 300 | MG | FILM-COATED TABLET | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127045711 | 12704571 | 1 | Hypertension |
| 127045711 | 12704571 | 2 | Hypertension |
| 127045711 | 12704571 | 3 | Hypertension |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127045711 | 12704571 | Fatigue | Fatigue |
| 127045711 | 12704571 | Feeling abnormal | |
| 127045711 | 12704571 | General physical health deterioration | |
| 127045711 | 12704571 | Paraesthesia | Paraesthesia |
| 127045711 | 12704571 | Peripheral swelling | Peripheral swelling |
| 127045711 | 12704571 | Restlessness | Restlessness |
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 |
|---|---|---|---|---|---|---|
| 127045711 | 12704571 | 1 | 2007 | 0 | ||
| 127045711 | 12704571 | 2 | 201603 | 0 | ||
| 127045711 | 12704571 | 3 | 201604 | 0 |