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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126518501 | 12651850 | 1 | I | 20160620 | 20160802 | 20160815 | 20160815 | EXP | FR-JNJFOC-20160809486 | JANSSEN | 75.00 | YR | E | F | Y | 0.00000 | 20160815 | MD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126518501 | 12651850 | 1 | PS | IXPRIM | ACETAMINOPHENTRAMADOL HYDROCHLORIDE | 1 | Oral | Y | N | 21123 | 2 | DF | FILM COATED TABLET | QD | |||||
| 126518501 | 12651850 | 2 | SS | AMOXICILLIN. | AMOXICILLIN | 1 | Oral | Y | 0 | 1 | G | UNSPECIFIED | BID | ||||||
| 126518501 | 12651850 | 3 | C | ALDACTONE | SPIRONOLACTONE | 1 | Oral | 0 | 25 | MG | UNSPECIFIED | QD | |||||||
| 126518501 | 12651850 | 4 | C | CANDESARTAN CILEXETIL. | CANDESARTAN CILEXETIL | 1 | Oral | 0 | 4 | MG | UNSPECIFIED | QD | |||||||
| 126518501 | 12651850 | 5 | C | METFORMINE | METFORMIN HYDROCHLORIDE | 1 | Oral | 0 | 500 | MG | UNSPECIFIED | BID | |||||||
| 126518501 | 12651850 | 6 | C | CORTIVAZOL | CORTIVAZOL | 1 | Unknown | 0 | UNSPECIFIED |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126518501 | 12651850 | 1 | Product used for unknown indication |
| 126518501 | 12651850 | 2 | Dental care |
| 126518501 | 12651850 | 3 | Product used for unknown indication |
| 126518501 | 12651850 | 4 | Product used for unknown indication |
| 126518501 | 12651850 | 5 | Product used for unknown indication |
| 126518501 | 12651850 | 6 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126518501 | 12651850 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126518501 | 12651850 | Acute kidney injury | |
| 126518501 | 12651850 | Face oedema | |
| 126518501 | 12651850 | Oedema peripheral | |
| 126518501 | 12651850 | Rash | |
| 126518501 | 12651850 | Rash generalised |
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 |
|---|---|---|---|---|---|---|
| 126518501 | 12651850 | 2 | 20160614 | 20160619 | 0 | |
| 126518501 | 12651850 | 6 | 20160602 | 20160602 | 0 |