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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127753521 | 12775352 | 1 | I | 2016 | 20160906 | 20160923 | 20160923 | EXP | BR-JNJFOC-20160905386 | JANSSEN | 62.87 | YR | A | M | Y | 76.00000 | KG | 20160923 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127753521 | 12775352 | 1 | PS | SIMPONI | GOLIMUMAB | 1 | Subcutaneous | U | U | 125289 | 50 | MG | SOLUTION FOR INJECTION | /month | |||||
| 127753521 | 12775352 | 2 | SS | MORPHINE | MORPHINE | 1 | Unknown | U | 0 | UNSPECIFIED | |||||||||
| 127753521 | 12775352 | 3 | SS | CODEINE | CODEINE | 1 | Unknown | U | 0 | UNSPECIFIED | |||||||||
| 127753521 | 12775352 | 4 | C | LOSARTAN. | LOSARTAN | 1 | Unknown | D | 0 | UNSPECIFIED | |||||||||
| 127753521 | 12775352 | 5 | C | CALCIUM | CALCIUM | 1 | Unknown | D | 0 | UNSPECIFIED |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127753521 | 12775352 | 1 | Rheumatoid arthritis |
| 127753521 | 12775352 | 2 | Product used for unknown indication |
| 127753521 | 12775352 | 3 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127753521 | 12775352 | HO |
| 127753521 | 12775352 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127753521 | 12775352 | Asthenia | |
| 127753521 | 12775352 | Condition aggravated | |
| 127753521 | 12775352 | Depressed mood | |
| 127753521 | 12775352 | Diarrhoea | |
| 127753521 | 12775352 | Fall | |
| 127753521 | 12775352 | Spinal column injury | |
| 127753521 | 12775352 | Toxicity to various agents | |
| 127753521 | 12775352 | Weight decreased |
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 |
|---|---|---|---|---|---|---|
| 127753521 | 12775352 | 1 | 20160716 | 0 |