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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125455381 | 12545538 | 1 | I | 2006 | 20160627 | 20160711 | 20160711 | EXP | US-JNJFOC-20160625111 | JANSSEN | 0.00 | Y | 0.00000 | 20160711 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125455381 | 12545538 | 1 | PS | STELARA | USTEKINUMAB | 1 | Subcutaneous | U | U | 125261 | SOLUTION FOR INJECTION | ||||||||
| 125455381 | 12545538 | 2 | SS | HUMIRA | ADALIMUMAB | 1 | Subcutaneous | U | 0 | UNSPECIFIED | |||||||||
| 125455381 | 12545538 | 3 | SS | ENTYVIO | VEDOLIZUMAB | 1 | Unknown | U | 0 | UNSPECIFIED | |||||||||
| 125455381 | 12545538 | 4 | C | COLOSTRUM | 2 | Unknown | 0 | UNSPECIFIED |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125455381 | 12545538 | 1 | Crohn's disease |
| 125455381 | 12545538 | 2 | Crohn's disease |
| 125455381 | 12545538 | 3 | Crohn's disease |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125455381 | 12545538 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125455381 | 12545538 | Gastrointestinal fistula | |
| 125455381 | 12545538 | Gastrointestinal stenosis | |
| 125455381 | 12545538 | Intestinal resection | |
| 125455381 | 12545538 | Off label use | |
| 125455381 | 12545538 | 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 |
|---|---|---|---|---|---|---|
| 125455381 | 12545538 | 1 | 2006 | 0 | ||
| 125455381 | 12545538 | 2 | 2006 | 0 |