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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127448921 | 12744892 | 1 | I | 20151204 | 20160915 | 20160915 | EXP | CA-ROCHE-1673321 | ROCHE | 49.00 | YR | F | Y | 0.00000 | 20160915 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127448921 | 12744892 | 1 | PS | ACTEMRA | TOCILIZUMAB | 1 | Unknown | U | 125276 | ||||||||||
| 127448921 | 12744892 | 2 | SS | RITUXAN | RITUXIMAB | 1 | Intravenous (not otherwise specified) | 103705 | SOLUTION FOR INFUSION | ||||||||||
| 127448921 | 12744892 | 3 | SS | METHOTREXATE SODIUM. | METHOTREXATE SODIUM | 1 | Oral | 0 | |||||||||||
| 127448921 | 12744892 | 4 | SS | ARAVA | LEFLUNOMIDE | 1 | Unknown | U | 0 | TABLET | |||||||||
| 127448921 | 12744892 | 5 | SS | SULFASALAZINE. | SULFASALAZINE | 1 | Unknown | U | 0 | ||||||||||
| 127448921 | 12744892 | 6 | C | NAPROXEN. | NAPROXEN | 1 | 0 | ||||||||||||
| 127448921 | 12744892 | 7 | C | FOLIC ACID. | FOLIC ACID | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127448921 | 12744892 | 1 | Rheumatoid arthritis |
| 127448921 | 12744892 | 2 | Rheumatoid arthritis |
| 127448921 | 12744892 | 3 | Rheumatoid arthritis |
| 127448921 | 12744892 | 4 | Rheumatoid arthritis |
| 127448921 | 12744892 | 5 | Rheumatoid arthritis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127448921 | 12744892 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127448921 | 12744892 | Fatigue | |
| 127448921 | 12744892 | Gastrointestinal disorder | |
| 127448921 | 12744892 | Musculoskeletal stiffness | |
| 127448921 | 12744892 | Pneumonia | |
| 127448921 | 12744892 | Rash | |
| 127448921 | 12744892 | Rheumatoid nodule |
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 |
|---|---|---|---|---|---|---|
| 127448921 | 12744892 | 2 | 201510 | 0 | ||
| 127448921 | 12744892 | 3 | 201510 | 0 |