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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124259153 | 12425915 | 3 | F | 2016 | 20160908 | 20160601 | 20160912 | EXP | CA-JNJFOC-20160527307 | JANSSEN | 61.59 | YR | A | M | Y | 90.27000 | KG | 20160912 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124259153 | 12425915 | 1 | SS | SIMPONI | GOLIMUMAB | 1 | Subcutaneous | N | 15H051MV | 0 | 50 | MG | SOLUTION FOR INJECTION | ||||||
| 124259153 | 12425915 | 2 | PS | SIMPONI | GOLIMUMAB | 1 | Subcutaneous | N | 15H051MV | 125289 | 50 | MG | SOLUTION FOR INJECTION | ||||||
| 124259153 | 12425915 | 3 | SS | MELOXICAM. | MELOXICAM | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 124259153 | 12425915 | 4 | SS | METHOTREXATE. | METHOTREXATE | 1 | Unknown | 0 | UNSPECIFIED |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124259153 | 12425915 | 1 | Rheumatoid arthritis |
| 124259153 | 12425915 | 2 | Gastrointestinal haemorrhage |
| 124259153 | 12425915 | 3 | Product used for unknown indication |
| 124259153 | 12425915 | 4 | Product use issue |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124259153 | 12425915 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124259153 | 12425915 | Drug ineffective | |
| 124259153 | 12425915 | Gastric haemorrhage | |
| 124259153 | 12425915 | Hepatic enzyme increased | |
| 124259153 | 12425915 | Joint swelling | |
| 124259153 | 12425915 | Off label use | |
| 124259153 | 12425915 | Product use issue | |
| 124259153 | 12425915 | Rectal haemorrhage |
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 |
|---|---|---|---|---|---|---|
| 124259153 | 12425915 | 1 | 20160115 | 0 | ||
| 124259153 | 12425915 | 2 | 20160115 | 0 |