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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125320141 | 12532014 | 1 | I | 20160628 | 20160706 | 20160706 | EXP | CA-GLAXOSMITHKLINE-CA2016GSK095847 | GLAXOSMITHKLINE | 52.00 | YR | F | Y | 0.00000 | 20160706 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125320141 | 12532014 | 1 | PS | VOLTAREN | DICLOFENAC SODIUM | 1 | 22122 | ||||||||||||
| 125320141 | 12532014 | 2 | SS | METHOTREXATE. | METHOTREXATE | 1 | UNK | 0 | |||||||||||
| 125320141 | 12532014 | 3 | SS | METHOTREXATE. | METHOTREXATE | 1 | Oral | UNK | 0 | ||||||||||
| 125320141 | 12532014 | 4 | SS | SULFASALAZINE. | SULFASALAZINE | 1 | 1000 MG, BID | 0 | 1000 | MG | BID | ||||||||
| 125320141 | 12532014 | 5 | SS | PLAQUENIL | HYDROXYCHLOROQUINE SULFATE | 1 | 200 MG, BID | 0 | 200 | MG | BID | ||||||||
| 125320141 | 12532014 | 6 | SS | ARAVA | LEFLUNOMIDE | 1 | 20 MG, QOD | U | 0 | 20 | MG | QOD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125320141 | 12532014 | 1 | Product used for unknown indication |
| 125320141 | 12532014 | 2 | Rheumatoid arthritis |
| 125320141 | 12532014 | 4 | Rheumatoid arthritis |
| 125320141 | 12532014 | 5 | Product used for unknown indication |
| 125320141 | 12532014 | 6 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125320141 | 12532014 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125320141 | 12532014 | Diarrhoea | |
| 125320141 | 12532014 | Drug hypersensitivity | |
| 125320141 | 12532014 | Drug ineffective | |
| 125320141 | 12532014 | Drug intolerance | |
| 125320141 | 12532014 | Neutropenia | |
| 125320141 | 12532014 | Skin hyperpigmentation | |
| 125320141 | 12532014 | White blood cell count decreased |
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 |
|---|---|---|---|---|---|---|
| 125320141 | 12532014 | 2 | 2009 | 2012 | 0 | |
| 125320141 | 12532014 | 3 | 2012 | 2015 | 0 | |
| 125320141 | 12532014 | 4 | 201309 | 0 | ||
| 125320141 | 12532014 | 5 | 201309 | 201603 | 0 |