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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 118036892 | 11803689 | 2 | F | 20160718 | 20151204 | 20160802 | EXP | CA-CONCORDIA PHARMACEUTICALS INC.-CO-PL-CA-2015-400 | CONCORDIA | 0.00 | F | Y | 0.00000 | 20160802 | MD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 118036892 | 11803689 | 1 | PS | PLAQUENIL | HYDROXYCHLOROQUINE SULFATE | 1 | Unknown | U | 9768 | 400 | MG | QD | |||||||
| 118036892 | 11803689 | 2 | SS | ARAVA | LEFLUNOMIDE | 1 | Unknown | 0 | 20 | MG | QD | ||||||||
| 118036892 | 11803689 | 3 | C | PREDNISONE. | PREDNISONE | 1 | 0 | ||||||||||||
| 118036892 | 11803689 | 4 | C | METHOTREXATE. | METHOTREXATE | 1 | 0 | ||||||||||||
| 118036892 | 11803689 | 5 | C | SULFASALAZINE. | SULFASALAZINE | 1 | 0 | ||||||||||||
| 118036892 | 11803689 | 6 | C | ENBREL | ETANERCEPT | 1 | 0 | ||||||||||||
| 118036892 | 11803689 | 7 | C | HUMIRA | ADALIMUMAB | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 118036892 | 11803689 | 1 | Rheumatoid arthritis |
| 118036892 | 11803689 | 2 | Rheumatoid arthritis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 118036892 | 11803689 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 118036892 | 11803689 | Abdominal discomfort | |
| 118036892 | 11803689 | Drug ineffective | |
| 118036892 | 11803689 | Nausea | |
| 118036892 | 11803689 | Rheumatoid arthritis |
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 |
|---|---|---|---|---|---|---|
| 118036892 | 11803689 | 1 | 201003 | 201009 | 0 | |
| 118036892 | 11803689 | 2 | 201309 | 20150330 | 0 | |
| 118036892 | 11803689 | 4 | 20100323 | 201208 | 0 | |
| 118036892 | 11803689 | 5 | 201009 | 201009 | 0 | |
| 118036892 | 11803689 | 6 | 20141216 | 20150615 | 0 | |
| 118036892 | 11803689 | 7 | 20150615 | 20151103 | 0 |