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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125289361 | 12528936 | 1 | I | 20150317 | 20160705 | 20160705 | EXP | CA-PFIZER INC-2015097304 | PFIZER | 61.00 | YR | F | Y | 0.00000 | 20160705 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125289361 | 12528936 | 1 | PS | METHOTREXATE SODIUM. | METHOTREXATE SODIUM | 1 | 25 MG, WEEKLY | 11719 | 25 | MG | /wk | ||||||||
| 125289361 | 12528936 | 2 | SS | FOLIC ACID. | FOLIC ACID | 1 | WEEKLY | 5897 | /wk | ||||||||||
| 125289361 | 12528936 | 3 | SS | ARAVA | LEFLUNOMIDE | 1 | Oral | 20 MG, 1X/DAY | N | 0 | 20 | MG | QD | ||||||
| 125289361 | 12528936 | 4 | SS | PLAQUENIL | HYDROXYCHLOROQUINE SULFATE | 1 | 200 MG, 1X/DAY (EVERYDAY BESIDES SUNDAYS) | 0 | 1200 | MG | /wk | ||||||||
| 125289361 | 12528936 | 5 | SS | CIMZIA | CERTOLIZUMAB PEGOL | 1 | 200 MG, EVERY 2 WEEKS | N | 0 | 200 | MG | ||||||||
| 125289361 | 12528936 | 6 | SS | HUMIRA | ADALIMUMAB | 1 | N | 0 | |||||||||||
| 125289361 | 12528936 | 7 | SS | ACTEMRA | TOCILIZUMAB | 1 | Intravenous (not otherwise specified) | 281 MG, EVERY 4 WEEKS | N | 0 | 281 | MG | |||||||
| 125289361 | 12528936 | 8 | SS | ACTEMRA | TOCILIZUMAB | 1 | Subcutaneous | 162 MG, WEEKLY | N | 0 | 162 | MG | /wk | ||||||
| 125289361 | 12528936 | 9 | SS | PREDNISONE. | PREDNISONE | 1 | 2 DF, ALTERNATE DAY (EVERY SECOND DAY FOR THE NEXT 2 WEEKS) | 0 | 2 | DF | QOD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125289361 | 12528936 | 1 | Rheumatoid arthritis |
| 125289361 | 12528936 | 3 | Rheumatoid arthritis |
| 125289361 | 12528936 | 4 | Rheumatoid arthritis |
| 125289361 | 12528936 | 5 | Rheumatoid arthritis |
| 125289361 | 12528936 | 6 | Rheumatoid arthritis |
| 125289361 | 12528936 | 7 | Rheumatoid arthritis |
| 125289361 | 12528936 | 9 | Swelling |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125289361 | 12528936 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125289361 | 12528936 | Drug dose omission | |
| 125289361 | 12528936 | Drug ineffective | |
| 125289361 | 12528936 | Fatigue | |
| 125289361 | 12528936 | Gait disturbance | |
| 125289361 | 12528936 | Neurogenic bladder | |
| 125289361 | 12528936 | 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 |
|---|---|---|---|---|---|---|
| 125289361 | 12528936 | 1 | 201201 | 0 | ||
| 125289361 | 12528936 | 3 | 201209 | 201310 | 0 | |
| 125289361 | 12528936 | 4 | 201201 | 0 | ||
| 125289361 | 12528936 | 5 | 201310 | 201312 | 0 | |
| 125289361 | 12528936 | 7 | 201403 | 201410 | 0 | |
| 125289361 | 12528936 | 8 | 201410 | 201506 | 0 |