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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 122823324 | 12282332 | 4 | F | 201507 | 20160711 | 20160419 | 20160715 | EXP | JP-JNJFOC-20160416653 | JANSSEN | HASHIMOTO Y. A CASE OF ULCERATIVE COLITIS WITH ENTEROPATHIC ARTHRITIS WHO WAS TREATED EFFECTIVELY AFTER SWITCHING OF BIOLOGICS. 2016:639. HASHIMOTO Y. P3-093: SWITCHING EFFECT OF BIOLOGICS ON GASTROINTESTINAL AND ASSOCIATED ARTICULAR INFLAMMATION: A CASE REPORT. 60TH ANNUAL GENERAL ASSEMBLY AND SCIENTIFIC MEETING OF THE JAPAN COLLEGE OF RHEUMATOLOGY APR-2016:S318. | 32.00 | YR | A | F | Y | 0.00000 | 20160715 | OT | JP | JP |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 122823324 | 12282332 | 1 | PS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | Y | N | UNKNOWN | 103772 | LYOPHILIZED POWDER |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 122823324 | 12282332 | 1 | Colitis ulcerative |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 122823324 | 12282332 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 122823324 | 12282332 | Arthritis enteropathic | |
| 122823324 | 12282332 | Drug effect decreased | |
| 122823324 | 12282332 | Drug specific antibody present |
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 |
|---|---|---|---|---|---|---|
| 122823324 | 12282332 | 1 | 201502 | 0 |