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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 116991194 | 11699119 | 4 | F | 20160811 | 20151104 | 20160825 | EXP | CA-CONCORDIA PHARMACEUTICALS INC.-CO-PL-CA-2015-343 | CONCORDIA | 59.00 | YR | F | Y | 0.00000 | 20160825 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 116991194 | 11699119 | 1 | PS | PLAQUENIL | HYDROXYCHLOROQUINE SULFATE | 1 | Unknown | 9768 | 200 | MG | BID | ||||||||
| 116991194 | 11699119 | 2 | SS | METHOTREXATE SODIUM. | METHOTREXATE SODIUM | 1 | Subcutaneous | 0 | 25 | MG | /wk | ||||||||
| 116991194 | 11699119 | 3 | SS | METHOTREXATE SODIUM. | METHOTREXATE SODIUM | 1 | Subcutaneous | 0 | 200 | MG | BID | ||||||||
| 116991194 | 11699119 | 4 | SS | METHOTREXATE SODIUM. | METHOTREXATE SODIUM | 1 | Subcutaneous | 0 | 20 | MG | |||||||||
| 116991194 | 11699119 | 5 | SS | XELJANZ | TOFACITINIB CITRATE | 1 | Oral | 0 | 5 | MG | BID | ||||||||
| 116991194 | 11699119 | 6 | SS | XELJANZ | TOFACITINIB CITRATE | 1 | Oral | 0 | 5 | MG | BID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 116991194 | 11699119 | 1 | Rheumatoid arthritis |
| 116991194 | 11699119 | 2 | Rheumatoid arthritis |
| 116991194 | 11699119 | 5 | Rheumatoid arthritis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 116991194 | 11699119 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 116991194 | 11699119 | Arthralgia | |
| 116991194 | 11699119 | C-reactive protein increased | |
| 116991194 | 11699119 | Joint swelling | |
| 116991194 | 11699119 | Kidney infection | |
| 116991194 | 11699119 | Nephrolithiasis | |
| 116991194 | 11699119 | 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 |
|---|---|---|---|---|---|---|
| 116991194 | 11699119 | 1 | 201412 | 0 | ||
| 116991194 | 11699119 | 4 | 20150217 | 0 | ||
| 116991194 | 11699119 | 5 | 20150121 | 20150526 | 0 | |
| 116991194 | 11699119 | 6 | 2015 | 201509 | 0 |