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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123643472 | 12364347 | 2 | F | 20150801 | 20160825 | 20160513 | 20160909 | EXP | CA-CONCORDIA PHARMACEUTICALS INC.-CO-PL-CA-2016-221 | CONCORDIA | 65.00 | YR | F | Y | 0.00000 | 20160909 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123643472 | 12364347 | 1 | PS | PLAQUENIL | HYDROXYCHLOROQUINE SULFATE | 1 | 9768 | ||||||||||||
| 123643472 | 12364347 | 2 | SS | PLAQUENIL | HYDROXYCHLOROQUINE SULFATE | 1 | 9768 | ||||||||||||
| 123643472 | 12364347 | 3 | SS | ARAVA | LEFLUNOMIDE | 1 | 0 | ||||||||||||
| 123643472 | 12364347 | 4 | SS | XELJANZ | TOFACITINIB CITRATE | 1 | Oral | 0 | 5 | MG | BID | ||||||||
| 123643472 | 12364347 | 5 | C | METHOTREXATE. | METHOTREXATE | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 123643472 | 12364347 | 1 | Product used for unknown indication |
| 123643472 | 12364347 | 3 | Product used for unknown indication |
| 123643472 | 12364347 | 4 | Rheumatoid arthritis |
| 123643472 | 12364347 | 5 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 123643472 | 12364347 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 123643472 | 12364347 | Bone pain | |
| 123643472 | 12364347 | Burning sensation | |
| 123643472 | 12364347 | Condition aggravated | |
| 123643472 | 12364347 | Diarrhoea | |
| 123643472 | 12364347 | Fatigue | |
| 123643472 | 12364347 | Limb mass | |
| 123643472 | 12364347 | Malaise | |
| 123643472 | 12364347 | Peripheral embolism | |
| 123643472 | 12364347 | Peripheral swelling | |
| 123643472 | 12364347 | Sciatica | |
| 123643472 | 12364347 | Urinary tract infection |
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 |
|---|---|---|---|---|---|---|
| 123643472 | 12364347 | 1 | 2016 | 0 | ||
| 123643472 | 12364347 | 3 | 2016 | 0 | ||
| 123643472 | 12364347 | 4 | 20150801 | 201602 | 0 |