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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125839041 | 12583904 | 1 | I | 20160712 | 20160722 | 20160722 | EXP | NL-JNJFOC-20160712595 | JANSSEN | DUIJVIS NW, TEN HOVE AS, PONSIOEN CI, VAN DEN BRINK GR, LOWENBERGB M, D^HAENS GR, ET AL. SIMILAR SHORT- AND LONG-TERM COLECTOMY RATES WITH CICLOSPORIN AND INFLIXIMAB TREATMENT INHOSPITALISED ULCERATIVE COLITIS PATIENTS. J CROHNS COLITIS 2016;10(7):821-827. | 0.00 | Y | 0.00000 | 20160722 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125839041 | 12583904 | 1 | PS | INFLIXIMAB, RECOMBINANT | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | AT WEEK 0, WEEK 2 AND WEEK 6 LATER AT 8 WEEKS MAINTENANCE TREATMENT | U | UNKNOWN | 103772 | 5 | MG/KG | LYOPHILIZED POWDER | |||||
| 125839041 | 12583904 | 2 | C | THIOPURINOL | 2 | Unknown | 0 | ||||||||||||
| 125839041 | 12583904 | 3 | C | MESALAZINE | MESALAMINE | 1 | Unknown | 0 | UNKNOWN |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125839041 | 12583904 | 1 | Colitis ulcerative |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125839041 | 12583904 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125839041 | 12583904 | Adverse drug reaction | |
| 125839041 | 12583904 | Colectomy | |
| 125839041 | 12583904 | Drug ineffective |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |