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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 122258423 | 12225842 | 3 | F | 2015 | 20160803 | 20160331 | 20160823 | EXP | BR-JNJFOC-20160328776 | JANSSEN | 0.00 | T | F | Y | 0.00000 | 20160823 | CN | BR | BR |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 122258423 | 12225842 | 1 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | U | UNKNOWN | 0 | 300 | MG | LYOPHILIZED POWDER | ||||||
| 122258423 | 12225842 | 2 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | U | UNKNOWN | 0 | 300 | MG | LYOPHILIZED POWDER | ||||||
| 122258423 | 12225842 | 3 | PS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | U | UNKNOWN | 103772 | 300 | MG | LYOPHILIZED POWDER | ||||||
| 122258423 | 12225842 | 4 | SS | HUMIRA | ADALIMUMAB | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 122258423 | 12225842 | 5 | C | AZATHIOPRINE. | AZATHIOPRINE | 1 | Unknown | 0 | UNSPECIFIED |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 122258423 | 12225842 | 1 | Crohn's disease |
| 122258423 | 12225842 | 2 | Crohn's disease |
| 122258423 | 12225842 | 3 | Crohn's disease |
| 122258423 | 12225842 | 4 | Crohn's disease |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 122258423 | 12225842 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 122258423 | 12225842 | Arthralgia | |
| 122258423 | 12225842 | Joint swelling | |
| 122258423 | 12225842 | Tuberculosis |
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 |
|---|---|---|---|---|---|---|
| 122258423 | 12225842 | 1 | 20160505 | 0 | ||
| 122258423 | 12225842 | 2 | 20160518 | 2016 | 0 | |
| 122258423 | 12225842 | 3 | 20120601 | 201508 | 0 | |
| 122258423 | 12225842 | 4 | 201508 | 2015 | 0 |