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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
117587643 | 11758764 | 3 | F | 20151117 | 20151120 | 20160922 | EXP | CZ-JNJFOC-20151118828 | JANSSEN | BORTLIK M, DURICOVA D, MACHKOVA N, HRUBA V, LUKAS M, MITROVA K, ET AL. DISCONTINUATION OF ANTI-TUMOR NECROSIS FACTOR THERAPY IN INFLAMMATORY BOWEL DISEASE PATIENTS: A PROSPECTIVE OBSERVATION. SCANDINAVIAN JOURNAL OF GASTROENTEROLOGY 01-SEP-2015;51/2:196-202. | 0.00 | Y | 0.00000 | 20160922 | OT | CZ | CZ |
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
117587643 | 11758764 | 1 | SS | INFLIXIMAB, RECOMBINANT | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | U | U | UNKNOWN | 0 | LYOPHILIZED POWDER | |||||||
117587643 | 11758764 | 2 | PS | INFLIXIMAB, RECOMBINANT | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | U | U | UNKNOWN | 103772 | LYOPHILIZED POWDER |
Indications of drugs used
Event ID | CASEID | INDI DRUG SEQ | INDI PT |
---|---|---|---|
117587643 | 11758764 | 1 | Colitis ulcerative |
117587643 | 11758764 | 2 | Colitis ulcerative |
Outcome of event
Event ID | CASEID | OUTC COD |
---|---|---|
117587643 | 11758764 | OT |
Reactions reported
Event ID | CASEID | DRUG REC ACT | PT |
---|---|---|---|
117587643 | 11758764 | Drug ineffective |
Reporting Sources (this data is often not reported and may therefore be missing here)
no results found |
Therapies reported
no results found |