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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123224002 | 12322400 | 2 | F | 20151108 | 20160721 | 20160502 | 20160802 | EXP | BR-JNJFOC-20151114139 | JANSSEN | 77.12 | YR | E | F | Y | 52.00000 | KG | 20160802 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123224002 | 12322400 | 1 | SS | SIMPONI | GOLIMUMAB | 1 | Subcutaneous | Y | U | UNKNOWN | 0 | SOLUTION FOR INJECTION | |||||||
| 123224002 | 12322400 | 2 | PS | SIMPONI | GOLIMUMAB | 1 | Subcutaneous | Y | U | UNKNOWN | 125289 | SOLUTION FOR INJECTION | |||||||
| 123224002 | 12322400 | 3 | SS | ETANERCEPT | ETANERCEPT | 1 | Unknown | Y | 0 | UNSPECIFIED | |||||||||
| 123224002 | 12322400 | 4 | C | PREDNISONE. | PREDNISONE | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 123224002 | 12322400 | 5 | C | ARAVA | LEFLUNOMIDE | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 123224002 | 12322400 | 6 | C | METICORTEN | PREDNISONE | 1 | Unknown | 0 | UNSPECIFIED |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 123224002 | 12322400 | 1 | Rheumatoid arthritis |
| 123224002 | 12322400 | 2 | Rheumatoid arthritis |
| 123224002 | 12322400 | 3 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 123224002 | 12322400 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 123224002 | 12322400 | Arthralgia | |
| 123224002 | 12322400 | Chills | |
| 123224002 | 12322400 | Cough | |
| 123224002 | 12322400 | Device issue | |
| 123224002 | 12322400 | Drug ineffective | |
| 123224002 | 12322400 | Feeling cold | |
| 123224002 | 12322400 | Hiccups | |
| 123224002 | 12322400 | Implant site swelling | |
| 123224002 | 12322400 | Pain in extremity | |
| 123224002 | 12322400 | Peripheral swelling | |
| 123224002 | 12322400 | Pyrexia |
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 |
|---|---|---|---|---|---|---|
| 123224002 | 12322400 | 1 | 20151015 | 201603 | 0 | |
| 123224002 | 12322400 | 2 | 20160413 | 20160613 | 0 |