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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
122725063 | 12272506 | 3 | F | 2016 | 20160408 | 20160415 | 20160722 | EXP | CA-JNJFOC-20160409461 | JANSSEN | 0.00 | A | M | Y | 100.00000 | KG | 20160722 | OT | CA | CA |
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
122725063 | 12272506 | 1 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | DOSE : 52 WEEKS | Y | U | FJM90014;GAM08011 | 0 | 500 | MG | LYOPHILIZED POWDER | ||||
122725063 | 12272506 | 2 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | Y | U | FJM90014;GAM08011 | 0 | 500 | MG | LYOPHILIZED POWDER | |||||
122725063 | 12272506 | 3 | PS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | Y | U | FJM90014;GAM08011 | 103772 | 500 | MG | LYOPHILIZED POWDER |
Indications of drugs used
Event ID | CASEID | INDI DRUG SEQ | INDI PT |
---|---|---|---|
122725063 | 12272506 | 1 | Crohn's disease |
122725063 | 12272506 | 2 | Crohn's disease |
122725063 | 12272506 | 3 | Crohn's disease |
Outcome of event
Event ID | CASEID | OUTC COD |
---|---|---|
122725063 | 12272506 | OT |
Reactions reported
Event ID | CASEID | DRUG REC ACT | PT |
---|---|---|---|
122725063 | 12272506 | Abdominal pain lower | |
122725063 | 12272506 | Frequent bowel movements | |
122725063 | 12272506 | Otitis media |
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 |
---|---|---|---|---|---|---|
122725063 | 12272506 | 1 | 20160603 | 0 | ||
122725063 | 12272506 | 2 | 20160408 | 0 | ||
122725063 | 12272506 | 3 | 201402 | 0 |