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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124213885 | 12421388 | 5 | F | 20140131 | 20160823 | 20160531 | 20160829 | EXP | DE-JNJFOC-20160518762 | JANSSEN | 3.00 | DEC | A | F | Y | 54.00000 | KG | 20160829 | MD | DE | DE |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124213885 | 12421388 | 1 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | 0 | LYOPHILIZED POWDER | |||||||||
| 124213885 | 12421388 | 2 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | 0 | LYOPHILIZED POWDER | |||||||||
| 124213885 | 12421388 | 3 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | 0 | 400 | MG | LYOPHILIZED POWDER | /month | ||||||
| 124213885 | 12421388 | 4 | PS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | 103772 | LYOPHILIZED POWDER | |||||||||
| 124213885 | 12421388 | 5 | C | CLAVERSAL | MESALAMINE | 1 | Unknown | 0 | 3 | G | UNSPECIFIED |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124213885 | 12421388 | 1 | Crohn's disease |
| 124213885 | 12421388 | 2 | Crohn's disease |
| 124213885 | 12421388 | 3 | Crohn's disease |
| 124213885 | 12421388 | 4 | Crohn's disease |
| 124213885 | 12421388 | 5 | Crohn's disease |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124213885 | 12421388 | OT |
| 124213885 | 12421388 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124213885 | 12421388 | Abdominal pain lower | |
| 124213885 | 12421388 | Anal abscess | |
| 124213885 | 12421388 | Anal fissure | |
| 124213885 | 12421388 | Anal fistula | |
| 124213885 | 12421388 | Anal stenosis | |
| 124213885 | 12421388 | Constipation | |
| 124213885 | 12421388 | Diarrhoea | |
| 124213885 | 12421388 | Endometriosis | |
| 124213885 | 12421388 | Fistula | |
| 124213885 | 12421388 | Flatulence | |
| 124213885 | 12421388 | Haematochezia | |
| 124213885 | 12421388 | Headache | |
| 124213885 | 12421388 | Initial insomnia | |
| 124213885 | 12421388 | Intestinal stenosis | |
| 124213885 | 12421388 | Large intestinal stenosis | |
| 124213885 | 12421388 | Proctitis ulcerative | |
| 124213885 | 12421388 | Pruritus | |
| 124213885 | 12421388 | Rectal fissure |
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 |
|---|---|---|---|---|---|---|
| 124213885 | 12421388 | 1 | 20160404 | 0 | ||
| 124213885 | 12421388 | 2 | 20150929 | 0 | ||
| 124213885 | 12421388 | 3 | 20140131 | 0 | ||
| 124213885 | 12421388 | 4 | 20160414 | 0 | ||
| 124213885 | 12421388 | 5 | 2012 | 0 |