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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 118002076 | 11800207 | 6 | F | 20160714 | 20151203 | 20160720 | EXP | CA-AMGEN-KDL279454 | AMGEN | 53.00 | YR | A | F | Y | 0.00000 | 20160720 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 118002076 | 11800207 | 1 | PS | ENBREL | ETANERCEPT | 1 | Subcutaneous | UNK UNK, QWK | 103795 | SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE | /wk | ||||||||
| 118002076 | 11800207 | 2 | SS | CIMZIA | CERTOLIZUMAB PEGOL | 1 | Subcutaneous | UNK | 0 | ||||||||||
| 118002076 | 11800207 | 3 | SS | HUMIRA | ADALIMUMAB | 1 | Subcutaneous | 0 | |||||||||||
| 118002076 | 11800207 | 4 | SS | METHOTREXATE SODIUM. | METHOTREXATE SODIUM | 1 | Unknown | UNK | 0 | TABLET | |||||||||
| 118002076 | 11800207 | 5 | SS | PLAQUENIL | HYDROXYCHLOROQUINE SULFATE | 1 | Unknown | UNK | 0 | TABLET | |||||||||
| 118002076 | 11800207 | 6 | SS | SIMPONI | GOLIMUMAB | 1 | Subcutaneous | UNK | 0 | ||||||||||
| 118002076 | 11800207 | 7 | SS | SULFASALAZINE. | SULFASALAZINE | 1 | Unknown | UNK | 0 | ||||||||||
| 118002076 | 11800207 | 8 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | UNK | 0 | ||||||||||
| 118002076 | 11800207 | 9 | SS | RITUXAN | RITUXIMAB | 1 | Intravenous (not otherwise specified) | UNK | 0 | ||||||||||
| 118002076 | 11800207 | 10 | SS | LEFLUNOMIDE. | LEFLUNOMIDE | 1 | Unknown | UNK | 0 | TABLET | |||||||||
| 118002076 | 11800207 | 11 | SS | ORENCIA | ABATACEPT | 1 | Unknown | UNK | 0 | ||||||||||
| 118002076 | 11800207 | 12 | C | PREDNISONE. | PREDNISONE | 1 | Oral | 10 MG, QD | 0 | 10 | MG | QD | |||||||
| 118002076 | 11800207 | 13 | C | PREDNISONE. | PREDNISONE | 1 | Oral | 6 MG, QD | 0 | 6 | MG | QD | |||||||
| 118002076 | 11800207 | 14 | C | ADVIL | IBUPROFEN | 1 | UNK | 0 | |||||||||||
| 118002076 | 11800207 | 15 | C | TYLENOL | ACETAMINOPHEN | 1 | UNK | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 118002076 | 11800207 | 1 | Rheumatoid arthritis |
| 118002076 | 11800207 | 2 | Rheumatoid arthritis |
| 118002076 | 11800207 | 3 | Rheumatoid arthritis |
| 118002076 | 11800207 | 4 | Rheumatoid arthritis |
| 118002076 | 11800207 | 5 | Rheumatoid arthritis |
| 118002076 | 11800207 | 6 | Rheumatoid arthritis |
| 118002076 | 11800207 | 7 | Rheumatoid arthritis |
| 118002076 | 11800207 | 8 | Rheumatoid arthritis |
| 118002076 | 11800207 | 9 | Rheumatoid arthritis |
| 118002076 | 11800207 | 10 | Rheumatoid arthritis |
| 118002076 | 11800207 | 11 | Rheumatoid arthritis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 118002076 | 11800207 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 118002076 | 11800207 | Activities of daily living impaired | |
| 118002076 | 11800207 | Drug ineffective | |
| 118002076 | 11800207 | Drug intolerance | |
| 118002076 | 11800207 | Fatigue | |
| 118002076 | 11800207 | Irritable bowel syndrome | |
| 118002076 | 11800207 | Malaise | |
| 118002076 | 11800207 | Nausea | |
| 118002076 | 11800207 | Rheumatoid arthritis | |
| 118002076 | 11800207 | Stress |
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 |
|---|---|---|---|---|---|---|
| 118002076 | 11800207 | 1 | 200710 | 200804 | 0 |