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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127104591 | 12710459 | 1 | I | 20160803 | 20160902 | 20160902 | EXP | CA-ORION CORPORATION ORION PHARMA-TREX2016-1340 | ORION | 60.00 | YR | F | Y | 0.00000 | 20160902 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127104591 | 12710459 | 1 | PS | METHOTREXATE (TRADE NAME UNKNOWN) | METHOTREXATE | 1 | Unknown | Y | 0 | 10 | MG | ||||||||
| 127104591 | 12710459 | 2 | SS | METHOTREXATE (TRADE NAME UNKNOWN) | METHOTREXATE | 1 | Unknown | Y | 0 | 15 | MG | ||||||||
| 127104591 | 12710459 | 3 | SS | METHOTREXATE (TRADE NAME UNKNOWN) | METHOTREXATE | 1 | Unknown | Y | 0 | ||||||||||
| 127104591 | 12710459 | 4 | SS | SULFASALAZINE. | SULFASALAZINE | 1 | Unknown | Y | 0 | 500 | MG | TID | |||||||
| 127104591 | 12710459 | 5 | SS | SULFASALAZINE. | SULFASALAZINE | 1 | Unknown | Y | 0 | 1.5 | MG | BID | |||||||
| 127104591 | 12710459 | 6 | SS | GOLD | GOLD | 1 | Unknown | Y | 0 | 50 | MG | Q3W | |||||||
| 127104591 | 12710459 | 7 | SS | GOLD | GOLD | 1 | Unknown | Y | 0 | 10 | MG | ||||||||
| 127104591 | 12710459 | 8 | SS | PLAQUENIL | HYDROXYCHLOROQUINE SULFATE | 1 | Unknown | 0 | 200 | MG | BID | ||||||||
| 127104591 | 12710459 | 9 | SS | LEFLUNOMIDE. | LEFLUNOMIDE | 1 | Unknown | Y | 0 | 10 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127104591 | 12710459 | 1 | Rheumatoid arthritis |
| 127104591 | 12710459 | 4 | Rheumatoid arthritis |
| 127104591 | 12710459 | 6 | Rheumatoid arthritis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127104591 | 12710459 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127104591 | 12710459 | Abdominal discomfort | |
| 127104591 | 12710459 | Deafness | |
| 127104591 | 12710459 | Diarrhoea | |
| 127104591 | 12710459 | Drug intolerance | |
| 127104591 | 12710459 | Fatigue | |
| 127104591 | 12710459 | Menorrhagia | |
| 127104591 | 12710459 | Nausea | |
| 127104591 | 12710459 | Therapeutic response decreased | |
| 127104591 | 12710459 | 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 |
|---|---|---|---|---|---|---|
| 127104591 | 12710459 | 1 | 20050705 | 20080211 | 0 | |
| 127104591 | 12710459 | 2 | 20060529 | 20090625 | 0 | |
| 127104591 | 12710459 | 3 | 20051103 | 200601 | 0 | |
| 127104591 | 12710459 | 4 | 20080111 | 20081017 | 0 | |
| 127104591 | 12710459 | 5 | 20081017 | 20090223 | 0 | |
| 127104591 | 12710459 | 6 | 20091001 | 20130101 | 0 | |
| 127104591 | 12710459 | 7 | 20151202 | 20160119 | 0 | |
| 127104591 | 12710459 | 8 | 20050120 | 0 | ||
| 127104591 | 12710459 | 9 | 20110105 | 20120409 | 0 |