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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 122342832 | 12234283 | 2 | F | 20160714 | 20160404 | 20160729 | EXP | 000653599; E2B_00288155 | CA-CONCORDIA PHARMACEUTICALS INC.-CO-PL-CA-2016-164 | CONCORDIA | 61.00 | YR | F | Y | 0.00000 | 20160729 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 122342832 | 12234283 | 1 | PS | PLAQUENIL | HYDROXYCHLOROQUINE SULFATE | 1 | Unknown | U | 9768 | 200 | MG | BID | |||||||
| 122342832 | 12234283 | 2 | SS | PLAQUENIL | HYDROXYCHLOROQUINE SULFATE | 1 | Unknown | U | 9768 | 200 | MG | QD | |||||||
| 122342832 | 12234283 | 3 | SS | ARAVA | LEFLUNOMIDE | 1 | Oral | 0 | 20 | MG | QD | ||||||||
| 122342832 | 12234283 | 4 | SS | ACTEMRA | TOCILIZUMAB | 1 | Intravenous (not otherwise specified) | 0 | 281 | MG | /month | ||||||||
| 122342832 | 12234283 | 5 | SS | ACTEMRA | TOCILIZUMAB | 1 | Subcutaneous | 0 | 162 | MG | /wk | ||||||||
| 122342832 | 12234283 | 6 | SS | CIMZIA | CERTOLIZUMAB PEGOL | 1 | Unknown | 0 | 200 | MG | QOW | ||||||||
| 122342832 | 12234283 | 7 | SS | HUMIRA | ADALIMUMAB | 1 | Unknown | 0 | |||||||||||
| 122342832 | 12234283 | 8 | SS | LEUCOVORIN. | LEUCOVORIN | 1 | Unknown | 0 | /wk | ||||||||||
| 122342832 | 12234283 | 9 | SS | METHOTREXATE. | METHOTREXATE | 1 | Unknown | 0 | 25 | MG | /wk | ||||||||
| 122342832 | 12234283 | 10 | SS | PREDNISONE. | PREDNISONE | 1 | Unknown | 0 | 2 | DF | QOD | ||||||||
| 122342832 | 12234283 | 11 | SS | FOLIC ACID. | FOLIC ACID | 1 | 0 | /wk |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 122342832 | 12234283 | 1 | Rheumatoid arthritis |
| 122342832 | 12234283 | 3 | Rheumatoid arthritis |
| 122342832 | 12234283 | 4 | Rheumatoid arthritis |
| 122342832 | 12234283 | 6 | Rheumatoid arthritis |
| 122342832 | 12234283 | 7 | Rheumatoid arthritis |
| 122342832 | 12234283 | 8 | Rheumatoid arthritis |
| 122342832 | 12234283 | 9 | Rheumatoid arthritis |
| 122342832 | 12234283 | 10 | Swelling |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 122342832 | 12234283 | HO |
| 122342832 | 12234283 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 122342832 | 12234283 | Activities of daily living impaired | |
| 122342832 | 12234283 | Drug dose omission | |
| 122342832 | 12234283 | Drug ineffective | |
| 122342832 | 12234283 | Fatigue | |
| 122342832 | 12234283 | Gait disturbance | |
| 122342832 | 12234283 | Neurogenic bladder | |
| 122342832 | 12234283 | 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 |
|---|---|---|---|---|---|---|
| 122342832 | 12234283 | 1 | 201201 | 0 | ||
| 122342832 | 12234283 | 3 | 201209 | 201310 | 0 | |
| 122342832 | 12234283 | 4 | 201403 | 201410 | 0 | |
| 122342832 | 12234283 | 5 | 201410 | 201506 | 0 | |
| 122342832 | 12234283 | 6 | 201310 | 201312 | 0 | |
| 122342832 | 12234283 | 9 | 201201 | 0 |