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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125614881 | 12561488 | 1 | I | 20160704 | 20160715 | 20160715 | EXP | CA-CONCORDIA PHARMACEUTICALS INC.-CO-PL-CA-2016-388 | CONCORDIA | 0.00 | F | Y | 0.00000 | 20160715 | OT | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125614881 | 12561488 | 1 | PS | PLAQUENIL | HYDROXYCHLOROQUINE SULFATE | 1 | 9768 | 400 | MG | QD | |||||||||
| 125614881 | 12561488 | 2 | SS | LEFLUNOMIDE. | LEFLUNOMIDE | 1 | Oral | 0 | 10 | MG | QD | ||||||||
| 125614881 | 12561488 | 3 | SS | SULFASALAZINE. | SULFASALAZINE | 1 | 0 | 500 | MG | QD | |||||||||
| 125614881 | 12561488 | 4 | SS | AZATHIOPRINE. | AZATHIOPRINE | 1 | 0 | ||||||||||||
| 125614881 | 12561488 | 5 | SS | METHOTREXATE. | METHOTREXATE | 1 | 0 | 20 | MG | /wk |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125614881 | 12561488 | 1 | Product used for unknown indication |
| 125614881 | 12561488 | 2 | Product used for unknown indication |
| 125614881 | 12561488 | 3 | Rheumatoid arthritis |
| 125614881 | 12561488 | 4 | Product used for unknown indication |
| 125614881 | 12561488 | 5 | Rheumatoid arthritis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125614881 | 12561488 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125614881 | 12561488 | Diarrhoea | |
| 125614881 | 12561488 | Interstitial lung disease | |
| 125614881 | 12561488 | 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 |
|---|---|---|---|---|---|---|
| 125614881 | 12561488 | 1 | 201511 | 201512 | 0 | |
| 125614881 | 12561488 | 2 | 201509 | 201511 | 0 | |
| 125614881 | 12561488 | 3 | 201512 | 0 | ||
| 125614881 | 12561488 | 4 | 201511 | 201512 | 0 | |
| 125614881 | 12561488 | 5 | 201310 | 201511 | 0 |