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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124048033 | 12404803 | 3 | F | 2011 | 20160811 | 20160525 | 20160817 | EXP | CA-JNJFOC-20160519501 | JANSSEN | 53.79 | YR | A | M | Y | 93.40000 | KG | 20160817 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124048033 | 12404803 | 1 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | FOR 52 (UNIT UNSPECIFIED) | N | GAM08011 | 0 | 1000 | MG | LYOPHILIZED POWDER | |||||
| 124048033 | 12404803 | 2 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | FOR 52 (UNIT UNSPECIFIED) | N | GAM08011 | 0 | 1000 | MG | LYOPHILIZED POWDER | |||||
| 124048033 | 12404803 | 3 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | FOR 52 (UNIT UNSPECIFIED) | N | GAM08011 | 0 | 1000 | MG | LYOPHILIZED POWDER | |||||
| 124048033 | 12404803 | 4 | PS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | FOR 52 (UNIT UNSPECIFIED) | N | GAM08011 | 103772 | 1000 | MG | LYOPHILIZED POWDER | |||||
| 124048033 | 12404803 | 5 | C | COLESTID | COLESTIPOL HYDROCHLORIDE | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 124048033 | 12404803 | 6 | C | VITAMIN B12 | CYANOCOBALAMIN | 1 | Unknown | 0 | INJECTION | ||||||||||
| 124048033 | 12404803 | 7 | C | VITAMIN D | CHOLECALCIFEROL | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 124048033 | 12404803 | 8 | C | METHOTREXATE. | METHOTREXATE | 1 | Unknown | 0 | UNSPECIFIED |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124048033 | 12404803 | 1 | Crohn's disease |
| 124048033 | 12404803 | 2 | Crohn's disease |
| 124048033 | 12404803 | 3 | Crohn's disease |
| 124048033 | 12404803 | 4 | Crohn's disease |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124048033 | 12404803 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124048033 | 12404803 | Basal cell carcinoma | |
| 124048033 | 12404803 | Diarrhoea | |
| 124048033 | 12404803 | Off label use | |
| 124048033 | 12404803 | Product use issue |
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 |
|---|---|---|---|---|---|---|
| 124048033 | 12404803 | 1 | 2012 | 0 | ||
| 124048033 | 12404803 | 2 | 2011 | 0 | ||
| 124048033 | 12404803 | 3 | 2012 | 0 | ||
| 124048033 | 12404803 | 4 | 2011 | 0 |