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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125632261 | 12563226 | 1 | I | 20160628 | 20160707 | 20160715 | 20160715 | EXP | FR-TAKEDA-2016TUS012177 | TAKEDA | 28.00 | YR | M | Y | 0.00000 | 20160715 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125632261 | 12563226 | 1 | PS | Vedolizumab | VEDOLIZUMAB | 1 | Intravenous (not otherwise specified) | 300 MG, UNK | Y | 125476 | 300 | MG | INJECTION | ||||||
| 125632261 | 12563226 | 2 | SS | PREDNISOLONE. | PREDNISOLONE | 1 | Oral | 10 MG, UNK | 0 | 10 | MG | TABLET | |||||||
| 125632261 | 12563226 | 3 | C | OFLOCET /00731801/ | OFLOXACIN | 1 | 200 MG, QD | U | 0 | 200 | MG | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125632261 | 12563226 | 1 | Crohn's disease |
| 125632261 | 12563226 | 2 | Crohn's disease |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125632261 | 12563226 | HO |
| 125632261 | 12563226 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125632261 | 12563226 | Crohn's disease | |
| 125632261 | 12563226 | Sepsis |
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 |
|---|---|---|---|---|---|---|
| 125632261 | 12563226 | 1 | 20150916 | 20160614 | 0 | |
| 125632261 | 12563226 | 2 | 201510 | 0 |