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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 113803672 | 11380367 | 2 | F | 20160726 | 20150814 | 20160802 | EXP | US-JNJFOC-20150603013 | JANSSEN | SINGH S, SANGARALINGHAM LR, HEIEN H, ANDERSON SS, SHAH N, LOFTUS EV. COMPARATIVE EFFECTIVENESS AND SAFETY OF ANTI-TNF AGENTS FOR CROHN^S DISEASE IN BIOLOGIC-NAIVE PATIENTS. GASTROENTEROLOGY DIGESTIVE DISEASE WEEK MAY-2015;148 (4 SUPPL. 1):S175. SINGH S, HEIEN HC, SANGARALINGHAM LR, ANDERSON SS, SHAH N, LOFTUS EV, ET AL. COMPARATIVE EFFECTIVENESS AND SAFETY OF ANTI-TUMOR NECROSIS FACTOR AGENTS IN BIOLOGIC-NAIVE PATIENTS. CLINICAL GASTROENTEROLOGY + HEPATOLOGY 2016;14(8):1120-1129.E6. | 0.00 | A | Y | 0.00000 | 20160802 | MD | US | US |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 113803672 | 11380367 | 1 | PS | INFLIXIMAB, RECOMBINANT | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | U | U | 103772 | LYOPHILIZED POWDER | ||||||||
| 113803672 | 11380367 | 2 | SS | ADALIMUMAB | ADALIMUMAB | 1 | Unknown | U | 0 | UNSPECIFIED | |||||||||
| 113803672 | 11380367 | 3 | SS | CERTOLIZUMAB PEGOL | CERTOLIZUMAB PEGOL | 1 | Unknown | U | 0 | UNSPECIFIED | |||||||||
| 113803672 | 11380367 | 4 | C | MESALAZINE | MESALAMINE | 1 | Oral | 0 | UNSPECIFIED | ||||||||||
| 113803672 | 11380367 | 5 | C | AZATHIOPRINE. | AZATHIOPRINE | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 113803672 | 11380367 | 6 | C | 6-MERCAPTOPURINE | MERCAPTOPURINE | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 113803672 | 11380367 | 7 | C | METHOTREXATE. | METHOTREXATE | 1 | Unknown | 0 | UNSPECIFIED |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 113803672 | 11380367 | 1 | Crohn's disease |
| 113803672 | 11380367 | 2 | Product used for unknown indication |
| 113803672 | 11380367 | 3 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 113803672 | 11380367 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 113803672 | 11380367 | Infection |
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 |
|---|---|---|---|---|---|---|
| 113803672 | 11380367 | 1 | 2006 | 2014 | 0 |