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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127196801 | 12719680 | 1 | I | 2016 | 20160712 | 20160907 | 20160907 | PER | US-JNJFOC-20160710883 | JANSSEN | 0.00 | A | M | Y | 81.65000 | KG | 20160907 | CN | US | US |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127196801 | 12719680 | 1 | SS | SIMPONI | GOLIMUMAB | 1 | Subcutaneous | ABOUT A YEAR OR MORE AGO | N | N | UNKNOWN | 0 | 50 | MG | SOLUTION FOR INJECTION | /month | |||
| 127196801 | 12719680 | 2 | SS | SIMPONI | GOLIMUMAB | 1 | Subcutaneous | ABOUT A YEAR OR MORE AGO | N | N | UNKNOWN | 0 | 50 | MG | SOLUTION FOR INJECTION | /month | |||
| 127196801 | 12719680 | 3 | PS | SIMPONI | GOLIMUMAB | 1 | Subcutaneous | ABOUT A YEAR OR MORE AGO | N | N | UNKNOWN | 125289 | 50 | MG | SOLUTION FOR INJECTION | /month | |||
| 127196801 | 12719680 | 4 | SS | METOPROLOL. | METOPROLOL | 1 | Unknown | U | 0 | UNSPECIFIED |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127196801 | 12719680 | 1 | Colitis ulcerative |
| 127196801 | 12719680 | 2 | Ankylosing spondylitis |
| 127196801 | 12719680 | 3 | Rheumatoid arthritis |
| 127196801 | 12719680 | 4 | Hypertension |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127196801 | 12719680 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127196801 | 12719680 | Hypertension | |
| 127196801 | 12719680 | Off label use | |
| 127196801 | 12719680 | Product use issue | |
| 127196801 | 12719680 | Rheumatoid arthritis | |
| 127196801 | 12719680 | Skin disorder | |
| 127196801 | 12719680 | Urticaria |
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 |
|---|---|---|---|---|---|---|
| 127196801 | 12719680 | 1 | 201604 | 0 | ||
| 127196801 | 12719680 | 2 | 201604 | 0 | ||
| 127196801 | 12719680 | 3 | 201604 | 0 | ||
| 127196801 | 12719680 | 4 | 201605 | 0 |