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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125539082 | 12553908 | 2 | F | 20160719 | 20160713 | 20160801 | EXP | CA-HQ SPECIALTY-CA-2016INT000531 | INTERCHEM | 71.00 | YR | F | Y | 0.00000 | 20160801 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125539082 | 12553908 | 1 | PS | METHOTREXATE SODIUM. | METHOTREXATE SODIUM | 1 | 2.8571 MG (20 MG,1 IN 1 W) | 201749 | 20 | MG | |||||||||
| 125539082 | 12553908 | 2 | SS | METHOTREXATE SODIUM. | METHOTREXATE SODIUM | 1 | 15 MG, UNK | 201749 | 15 | MG | |||||||||
| 125539082 | 12553908 | 3 | SS | SALAZOPYRIN | SULFASALAZINE | 1 | Oral | 2 G (1 G, 2 IN 1 D) | U | 0 | 1 | G | |||||||
| 125539082 | 12553908 | 4 | SS | SALAZOPYRIN | SULFASALAZINE | 1 | UNK | U | 0 | ||||||||||
| 125539082 | 12553908 | 5 | SS | LEFLUNOMIDE. | LEFLUNOMIDE | 1 | 20 MG, 1 D | 0 | 20 | MG | |||||||||
| 125539082 | 12553908 | 6 | SS | HYDROXYCHLOROQUINE | HYDROXYCHLOROQUINE | 1 | 200 MG, UNK | 0 | 200 | MG | |||||||||
| 125539082 | 12553908 | 7 | SS | ORENCIA | ABATACEPT | 1 | Intravenous (not otherwise specified) | 750 MG, UNK | 0 | 750 | MG | INTRAVENOUS INFUSION | |||||||
| 125539082 | 12553908 | 8 | SS | RITUXAN | RITUXIMAB | 1 | Subcutaneous | 1 G, UNK | U | 0 | 1 | G | |||||||
| 125539082 | 12553908 | 9 | SS | SIMPONI | GOLIMUMAB | 1 | Subcutaneous | 1.6667 MG (50 MG, 1 IN 1 MO) | U | 0 | 50 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125539082 | 12553908 | 1 | Rheumatoid arthritis |
| 125539082 | 12553908 | 3 | Rheumatoid arthritis |
| 125539082 | 12553908 | 5 | Rheumatoid arthritis |
| 125539082 | 12553908 | 6 | Rheumatoid arthritis |
| 125539082 | 12553908 | 7 | Product used for unknown indication |
| 125539082 | 12553908 | 8 | Product used for unknown indication |
| 125539082 | 12553908 | 9 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125539082 | 12553908 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125539082 | 12553908 | Alanine aminotransferase increased | |
| 125539082 | 12553908 | Drug intolerance | |
| 125539082 | 12553908 | 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 |
|---|---|---|---|---|---|---|
| 125539082 | 12553908 | 1 | 20110804 | 201304 | 0 | |
| 125539082 | 12553908 | 3 | 20120425 | 20140501 | 0 | |
| 125539082 | 12553908 | 5 | 20130429 | 20140501 | 0 | |
| 125539082 | 12553908 | 6 | 20120425 | 201304 | 0 | |
| 125539082 | 12553908 | 7 | 2015 | 0 |