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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124892872 | 12489287 | 2 | F | 201309 | 20160731 | 20160622 | 20160802 | EXP | CA-JNJFOC-20160615046 | JANSSEN | ZHU J, ROACH B, KAO D. SUCCESSFUL ERADICATION OF RECURRENT CLOSTRIDIUM DIFFICILE INFECTION (RCDI) OF SMALL BOWEL WITH FROZEN ENCAPSULATED FECAL MICROBIOTA TRANSPLANTATION (FMT) IN A PATIENT WITH CROHN^S DISEASE AND ILEOSTOMY. CANADIAN J GASTROENTEROL HEPATOLOGY 2016:67-68. | 31.00 | YR | A | M | Y | 0.00000 | 20160802 | MD | CA | CA |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124892872 | 12489287 | 1 | SS | INFLIXIMAB, RECOMBINANT | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | U | U | UNKNOWN | 0 | 10 | MG/KG | LYOPHILIZED POWDER | |||||
| 124892872 | 12489287 | 2 | PS | INFLIXIMAB, RECOMBINANT | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | U | U | UNKNOWN | 103772 | 10 | MG/KG | LYOPHILIZED POWDER |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124892872 | 12489287 | 1 | Colitis ulcerative |
| 124892872 | 12489287 | 2 | Crohn's disease |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124892872 | 12489287 | OT |
| 124892872 | 12489287 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124892872 | 12489287 | Clostridium difficile infection | |
| 124892872 | 12489287 | Colectomy | |
| 124892872 | 12489287 | Drug ineffective | |
| 124892872 | 12489287 | Ileostomy | |
| 124892872 | 12489287 | Off label use | |
| 124892872 | 12489287 | Product use issue |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |