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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125905421 | 12590542 | 1 | I | 20150827 | 20160725 | 20160725 | EXP | CA-ROCHE-1627133 | ROCHE | 61.00 | YR | F | Y | 0.00000 | 20160726 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125905421 | 12590542 | 1 | PS | ACTEMRA | TOCILIZUMAB | 1 | Subcutaneous | U | 125472 | 162 | MG | SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE | /wk | ||||||
| 125905421 | 12590542 | 2 | SS | ACTEMRA | TOCILIZUMAB | 1 | Intravenous (not otherwise specified) | U | 125276 | 281 | MG | SOLUTION FOR INFUSION | |||||||
| 125905421 | 12590542 | 3 | SS | CIMZIA | CERTOLIZUMAB PEGOL | 1 | Unknown | U | 0 | 200 | MG | QOW | |||||||
| 125905421 | 12590542 | 4 | SS | FOLIC ACID. | FOLIC ACID | 1 | Unknown | U | 0 | /wk | |||||||||
| 125905421 | 12590542 | 5 | SS | HUMIRA | ADALIMUMAB | 1 | Unknown | U | 0 | ||||||||||
| 125905421 | 12590542 | 6 | SS | ARAVA | LEFLUNOMIDE | 1 | Oral | FREQUENCY: EVERY 1 DAY | U | 0 | 20 | MG | TABLET | ||||||
| 125905421 | 12590542 | 7 | SS | METHOTREXATE SODIUM. | METHOTREXATE SODIUM | 1 | Unknown | U | 0 | 25 | MG | /wk | |||||||
| 125905421 | 12590542 | 8 | SS | PLAQUENIL | HYDROXYCHLOROQUINE SULFATE | 1 | Unknown | EVERY DAY BESIDES SUNDAY | U | 0 | 200 | MG | TABLET | QD | |||||
| 125905421 | 12590542 | 9 | SS | PREDNISONE. | PREDNISONE | 1 | Unknown | U | 0 | 2 | DF | QOD | |||||||
| 125905421 | 12590542 | 10 | SS | XELJANZ | TOFACITINIB CITRATE | 1 | Oral | U | 0 | 5 | MG | BID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125905421 | 12590542 | 1 | Rheumatoid arthritis |
| 125905421 | 12590542 | 2 | Rheumatoid arthritis |
| 125905421 | 12590542 | 3 | Rheumatoid arthritis |
| 125905421 | 12590542 | 4 | Product used for unknown indication |
| 125905421 | 12590542 | 5 | Rheumatoid arthritis |
| 125905421 | 12590542 | 6 | Rheumatoid arthritis |
| 125905421 | 12590542 | 7 | Rheumatoid arthritis |
| 125905421 | 12590542 | 8 | Rheumatoid arthritis |
| 125905421 | 12590542 | 9 | Swelling |
| 125905421 | 12590542 | 10 | Rheumatoid arthritis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125905421 | 12590542 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125905421 | 12590542 | Activities of daily living impaired | |
| 125905421 | 12590542 | Drug dose omission | |
| 125905421 | 12590542 | Drug ineffective | |
| 125905421 | 12590542 | Fatigue | |
| 125905421 | 12590542 | Neurogenic bladder | |
| 125905421 | 12590542 | Pollakiuria |
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 |
|---|---|---|---|---|---|---|
| 125905421 | 12590542 | 1 | 201410 | 201506 | 0 | |
| 125905421 | 12590542 | 2 | 201403 | 201410 | 0 | |
| 125905421 | 12590542 | 3 | 201310 | 201312 | 0 | |
| 125905421 | 12590542 | 6 | 201209 | 201310 | 0 | |
| 125905421 | 12590542 | 7 | 201201 | 0 | ||
| 125905421 | 12590542 | 8 | 201201 | 0 | ||
| 125905421 | 12590542 | 10 | 20150327 | 0 |