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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124214033 | 12421403 | 3 | F | 2015 | 20160725 | 20160531 | 20160726 | EXP | FR-JNJFOC-20160527612 | JANSSEN | 0.00 | A | F | Y | 48.00000 | KG | 20160726 | MD | FR | FR |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124214033 | 12421403 | 1 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | 0 | 10 | MG/KG | LYOPHILIZED POWDER | |||||||
| 124214033 | 12421403 | 2 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | 0 | LYOPHILIZED POWDER | |||||||||
| 124214033 | 12421403 | 3 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | 0 | 10 | MG/KG | LYOPHILIZED POWDER | |||||||
| 124214033 | 12421403 | 4 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | 0 | LYOPHILIZED POWDER | |||||||||
| 124214033 | 12421403 | 5 | PS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | 103772 | 5 | MG/KG | LYOPHILIZED POWDER | |||||||
| 124214033 | 12421403 | 6 | C | IMUREL | AZATHIOPRINE SODIUM | 1 | Unknown | 0 | UNSPECIFIED |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124214033 | 12421403 | 1 | Crohn's disease |
| 124214033 | 12421403 | 2 | Crohn's disease |
| 124214033 | 12421403 | 3 | Crohn's disease |
| 124214033 | 12421403 | 4 | Crohn's disease |
| 124214033 | 12421403 | 5 | Crohn's disease |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124214033 | 12421403 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124214033 | 12421403 | Arthralgia | |
| 124214033 | 12421403 | Myocarditis | |
| 124214033 | 12421403 | Off label use | |
| 124214033 | 12421403 | 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 |
|---|---|---|---|---|---|---|
| 124214033 | 12421403 | 2 | 20140202 | 0 | ||
| 124214033 | 12421403 | 3 | 201604 | 0 | ||
| 124214033 | 12421403 | 4 | 2016 | 0 | ||
| 124214033 | 12421403 | 5 | 2013 | 0 |