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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 117789648 | 11778964 | 8 | F | 20160728 | 20151125 | 20160809 | EXP | CA-CONCORDIA PHARMACEUTICALS INC.-CO-PL-CA-2015-380 | CONCORDIA | 82.00 | YR | F | Y | 0.00000 | 20160809 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 117789648 | 11778964 | 1 | PS | PLAQUENIL | HYDROXYCHLOROQUINE SULFATE | 1 | Unknown | 9768 | 300 | MG | |||||||||
| 117789648 | 11778964 | 2 | SS | METHOTREXATE. | METHOTREXATE | 1 | Subcutaneous | 0 | 20 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 117789648 | 11778964 | 1 | Product used for unknown indication |
| 117789648 | 11778964 | 2 | Rheumatoid arthritis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 117789648 | 11778964 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 117789648 | 11778964 | Arthralgia | |
| 117789648 | 11778964 | Asthenia | |
| 117789648 | 11778964 | Depression | |
| 117789648 | 11778964 | Glomerular filtration rate decreased | |
| 117789648 | 11778964 | Pain in extremity | |
| 117789648 | 11778964 | Renal failure | |
| 117789648 | 11778964 | Treatment failure |
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 |
|---|---|---|---|---|---|---|
| 117789648 | 11778964 | 1 | 2015 | 0 | ||
| 117789648 | 11778964 | 2 | 2015 | 0 |