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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127372101 | 12737210 | 1 | I | 20160907 | 20160913 | 20160913 | EXP | NL-JNJFOC-20160908007 | JANSSEN | ZOET ID, DE BOER NK, DE MEIJ TG. SUCCESSFUL VEDOLIZUMAB THERAPY IN A SIXTEEN-YEAR-OLD BOY WITH REFRACTORY ULCERATIVE COLITIS.. J CROHNS COLITIS 15-NOV-2015:373-374. | 13.00 | YR | C | M | Y | 0.00000 | 20160913 | OT | NL | NL |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127372101 | 12737210 | 1 | PS | INFLIXIMAB, RECOMBINANT | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | Y | N | UNKNOWN | 103772 | LYOPHILIZED POWDER |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127372101 | 12737210 | 1 | Colitis ulcerative |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127372101 | 12737210 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127372101 | 12737210 | Colitis | |
| 127372101 | 12737210 | Drug ineffective |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |