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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 115290082 | 11529008 | 2 | F | 20160810 | 20150921 | 20160822 | EXP | CA-ORION CORPORATION ORION PHARMA-TREX2015-0580 | ORION | 75.00 | YR | F | Y | 0.00000 | 20160822 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 115290082 | 11529008 | 1 | PS | METHOTREXATE (TRADE NAME UNKNOWN) | METHOTREXATE | 1 | Unknown | U | 0 | 25 | MG | /wk | |||||||
| 115290082 | 11529008 | 2 | SS | SULFASALAZINE. | SULFASALAZINE | 1 | Unknown | U | 0 | ||||||||||
| 115290082 | 11529008 | 3 | SS | PLAQUENIL | HYDROXYCHLOROQUINE SULFATE | 1 | Unknown | U | 0 | ||||||||||
| 115290082 | 11529008 | 4 | SS | LEFLUNOMIDE. | LEFLUNOMIDE | 1 | Unknown | U | 0 | 20 | MG | ||||||||
| 115290082 | 11529008 | 5 | SS | HYDROXYCHLOROQUINE | HYDROXYCHLOROQUINE | 1 | Unknown | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 115290082 | 11529008 | 1 | Rheumatoid arthritis |
| 115290082 | 11529008 | 2 | Rheumatoid arthritis |
| 115290082 | 11529008 | 3 | Rheumatoid arthritis |
| 115290082 | 11529008 | 4 | Rheumatoid arthritis |
| 115290082 | 11529008 | 5 | Rheumatoid arthritis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 115290082 | 11529008 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 115290082 | 11529008 | Abdominal discomfort | |
| 115290082 | 11529008 | Drug intolerance | |
| 115290082 | 11529008 | Localised infection | |
| 115290082 | 11529008 | Nausea | |
| 115290082 | 11529008 | Pain | |
| 115290082 | 11529008 | Product quality issue | |
| 115290082 | 11529008 | Purulent discharge | |
| 115290082 | 11529008 | Treatment failure | |
| 115290082 | 11529008 | Vomiting |
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 |
|---|---|---|---|---|---|---|
| 115290082 | 11529008 | 1 | 20141006 | 20150330 | 0 | |
| 115290082 | 11529008 | 4 | 20150303 | 20150708 | 0 |