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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126227681 | 12622768 | 1 | I | 20160726 | 20160804 | 20160804 | EXP | ES-JNJFOC-20160800624 | JANSSEN | BOSCH OG, MONTSERRAT A, ORDAS I, ETCHEVERS J, SANS M, FEU F, ET AL. LONG-TERM FOLLOW-UP OF PATIENTS TREATED WITH INFLIXIMAB FOR ULCERATIVE COLITIS: PREDICTIVE FACTORS OF RESPONSE-AN BBSERVATIONAL STUDY. DIG DIS SCI 2016;61:20151-20159. | 0.00 | Y | 0.00000 | 20160804 | OT | ES | ES |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126227681 | 12622768 | 1 | PS | INFLIXIMAB, RECOMBINANT | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | AT WEEKS 0, 2, AND 6 FOR INDUCTION | U | U | 103772 | 5 | MG/KG | LYOPHILIZED POWDER |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126227681 | 12622768 | 1 | Colitis ulcerative |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126227681 | 12622768 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126227681 | 12622768 | Colectomy |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |