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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126789281 | 12678928 | 1 | I | 20160720 | 20160824 | 20160824 | EXP | CA-ORION CORPORATION ORION PHARMA-TREX2016-1147 | ORION | 68.00 | YR | F | Y | 0.00000 | 20160824 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126789281 | 12678928 | 1 | PS | METHOTREXATE (TRADE NAME UNKNOWN) | METHOTREXATE | 1 | Oral | 0 | 20 | MG | /wk | ||||||||
| 126789281 | 12678928 | 2 | SS | METHOTREXATE. | METHOTREXATE | 1 | Unknown | 0 | .8 | MG | INJECTION | /wk | |||||||
| 126789281 | 12678928 | 3 | SS | SULFASALAZINE. | SULFASALAZINE | 1 | Oral | 0 | 1 | G | BID | ||||||||
| 126789281 | 12678928 | 4 | C | DOMPERIDONE | DOMPERIDONE | 1 | Unknown | 0 | |||||||||||
| 126789281 | 12678928 | 5 | C | CRESTOR | ROSUVASTATIN CALCIUM | 1 | Unknown | 0 | |||||||||||
| 126789281 | 12678928 | 6 | C | CYMBALTA | DULOXETINE HYDROCHLORIDE | 1 | Unknown | 0 | |||||||||||
| 126789281 | 12678928 | 7 | C | ARAVA | LEFLUNOMIDE | 1 | Unknown | 0 | 20 | MG | QOD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126789281 | 12678928 | 1 | Rheumatoid arthritis |
| 126789281 | 12678928 | 2 | Rheumatoid arthritis |
| 126789281 | 12678928 | 3 | Rheumatoid arthritis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126789281 | 12678928 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126789281 | 12678928 | Arthralgia | |
| 126789281 | 12678928 | Drug ineffective | |
| 126789281 | 12678928 | Hepatic enzyme increased | |
| 126789281 | 12678928 | Joint swelling | |
| 126789281 | 12678928 | Latent tuberculosis |
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 |
|---|---|---|---|---|---|---|
| 126789281 | 12678928 | 1 | 201209 | 0 | ||
| 126789281 | 12678928 | 3 | 201603 | 201603 | 0 | |
| 126789281 | 12678928 | 7 | 201505 | 201603 | 0 |