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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127239501 | 12723950 | 1 | I | 2015 | 20160829 | 20160908 | 20160908 | EXP | CA-ORION CORPORATION ORION PHARMA-TREX2016-1659 | ORION | 59.00 | YR | F | Y | 0.00000 | 20160908 | CN | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127239501 | 12723950 | 1 | PS | METHOTREXATE (TRADE NAME UNKNOWN) | METHOTREXATE | 1 | Unknown | 0 | 25 | MG | /wk | ||||||||
| 127239501 | 12723950 | 2 | SS | SULFASALAZINE. | SULFASALAZINE | 1 | Unknown | N | 0 | 1 | G | BID | |||||||
| 127239501 | 12723950 | 3 | SS | PLAQUENIL | HYDROXYCHLOROQUINE SULFATE | 1 | Unknown | 0 | 400 | MG | QD | ||||||||
| 127239501 | 12723950 | 4 | SS | SIMPONI | GOLIMUMAB | 1 | Unknown | N | 0 | 50 | MG | ||||||||
| 127239501 | 12723950 | 5 | SS | PREDNISONE. | PREDNISONE | 1 | Unknown | N | 0 | 10 | MG | QD | |||||||
| 127239501 | 12723950 | 6 | SS | LEFLUNOMIDE. | LEFLUNOMIDE | 1 | Unknown | N | 0 | 20 | MG | QD | |||||||
| 127239501 | 12723950 | 7 | C | FOLIC ACID. | FOLIC ACID | 1 | Unknown | 0 | |||||||||||
| 127239501 | 12723950 | 8 | C | AMITRIPTYLINE | AMITRIPTYLINE | 1 | Unknown | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127239501 | 12723950 | 1 | Rheumatoid arthritis |
| 127239501 | 12723950 | 2 | Rheumatoid arthritis |
| 127239501 | 12723950 | 3 | Rheumatoid arthritis |
| 127239501 | 12723950 | 4 | Rheumatoid arthritis |
| 127239501 | 12723950 | 5 | Rheumatoid arthritis |
| 127239501 | 12723950 | 6 | Rheumatoid arthritis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127239501 | 12723950 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127239501 | 12723950 | Drug ineffective | |
| 127239501 | 12723950 | Fatigue | |
| 127239501 | 12723950 | Gait disturbance | |
| 127239501 | 12723950 | Insomnia | |
| 127239501 | 12723950 | Rheumatoid arthritis | |
| 127239501 | 12723950 | Sinusitis | |
| 127239501 | 12723950 | Stress | |
| 127239501 | 12723950 | Tinnitus |
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 |
|---|---|---|---|---|---|---|
| 127239501 | 12723950 | 1 | 20130801 | 0 | ||
| 127239501 | 12723950 | 2 | 20130930 | 20131113 | 0 | |
| 127239501 | 12723950 | 3 | 20131113 | 0 | ||
| 127239501 | 12723950 | 4 | 20150414 | 20151214 | 0 | |
| 127239501 | 12723950 | 5 | 20130801 | 0 | ||
| 127239501 | 12723950 | 6 | 20150227 | 20150316 | 0 |