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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 119317303 | 11931730 | 3 | F | 20160421 | 20160916 | 20160120 | 20160927 | EXP | ES-JNJFOC-20151218648 | JANSSEN | 32.35 | YR | A | F | Y | 61.00000 | KG | 20160927 | OT | ES | ES |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 119317303 | 11931730 | 1 | PS | STELARA | USTEKINUMAB | 1 | Subcutaneous | Y | N | 125261 | SOLUTION FOR INJECTION | ||||||||
| 119317303 | 11931730 | 2 | SS | ADVAGRAF | TACROLIMUS | 1 | Unknown | U | 0 | UNSPECIFIED | |||||||||
| 119317303 | 11931730 | 3 | C | AMOXICILLIN W/CLAVULANIC ACID | AMOXICILLINCLAVULANIC ACID | 1 | Unknown | D | 0 | UNSPECIFIED | |||||||||
| 119317303 | 11931730 | 4 | C | CLOTRIMAZOLE. | CLOTRIMAZOLE | 1 | Unknown | D | 0 | UNSPECIFIED | |||||||||
| 119317303 | 11931730 | 5 | C | FOSFOMYCIN | FOSFOMYCIN | 1 | Unknown | D | 0 | UNSPECIFIED | |||||||||
| 119317303 | 11931730 | 6 | C | FERBISOL | 2 | Unknown | D | 0 | UNSPECIFIED |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 119317303 | 11931730 | 1 | Crohn's disease |
| 119317303 | 11931730 | 2 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 119317303 | 11931730 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 119317303 | 11931730 | Exposure during pregnancy | |
| 119317303 | 11931730 | Off label use | |
| 119317303 | 11931730 | Premature separation of placenta | |
| 119317303 | 11931730 | Product use 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 |
|---|---|---|---|---|---|---|
| 119317303 | 11931730 | 2 | 19980715 | 0 | ||
| 119317303 | 11931730 | 3 | 20160711 | 20160721 | 0 | |
| 119317303 | 11931730 | 4 | 20160711 | 20160712 | 0 | |
| 119317303 | 11931730 | 5 | 20160624 | 20160626 | 0 | |
| 119317303 | 11931730 | 6 | 20160405 | 20160525 | 0 |