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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 75387652 | 7538765 | 2 | F | 20100623 | 20160711 | 20100812 | 20160713 | EXP | DK-JNJFOC-20100607927 | JANSSEN | 0.00 | A | F | Y | 63.00000 | KG | 20160713 | MD | DK | DK |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 75387652 | 7538765 | 1 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | 0 | 300 | MG | LYOPHILIZED POWDER | |||||||
| 75387652 | 7538765 | 2 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | 0 | LYOPHILIZED POWDER | |||||||||
| 75387652 | 7538765 | 3 | PS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | 103772 | 300 | MG | LYOPHILIZED POWDER | |||||||
| 75387652 | 7538765 | 4 | C | AZATHIOPRINE. | AZATHIOPRINE | 1 | Oral | 0 | 150 | MG | QD | ||||||||
| 75387652 | 7538765 | 5 | C | ASACOL | MESALAMINE | 1 | 0 | 1600 | MG | BID | |||||||||
| 75387652 | 7538765 | 6 | C | SOLU-MEDROL | METHYLPREDNISOLONE SODIUM SUCCINATE | 1 | Intravenous (not otherwise specified) | 0 | 60 | MG | |||||||||
| 75387652 | 7538765 | 7 | C | PREDNISOLON | PREDNISOLONE | 1 | 0 | 50 | MG | TABLET | |||||||||
| 75387652 | 7538765 | 8 | C | FERINJECT | FERRIC CARBOXYMALTOSE | 1 | 0 | 500 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 75387652 | 7538765 | 1 | Colitis ulcerative |
| 75387652 | 7538765 | 2 | Colitis ulcerative |
| 75387652 | 7538765 | 3 | Colitis ulcerative |
| 75387652 | 7538765 | 4 | Colitis ulcerative |
| 75387652 | 7538765 | 5 | Colitis ulcerative |
| 75387652 | 7538765 | 6 | Premedication |
| 75387652 | 7538765 | 7 | Premedication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 75387652 | 7538765 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 75387652 | 7538765 | Colitis ulcerative |
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 |
|---|---|---|---|---|---|---|
| 75387652 | 7538765 | 3 | 20100525 | 0 | ||
| 75387652 | 7538765 | 4 | 2009 | 0 | ||
| 75387652 | 7538765 | 5 | 20090713 | 0 | ||
| 75387652 | 7538765 | 7 | 20100524 | 0 | ||
| 75387652 | 7538765 | 8 | 20100708 | 0 |