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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125308641 | 12530864 | 1 | I | 20151013 | 20150805 | 20160706 | 20160706 | EXP | CA-AMGEN-CANSP2015081119 | AMGEN | 53.00 | YR | A | F | Y | 0.00000 | 20160706 | OT | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125308641 | 12530864 | 1 | PS | ENBREL | ETANERCEPT | 1 | Subcutaneous | UNK | U | 103795 | UNKNOWN FORMULATION | ||||||||
| 125308641 | 12530864 | 2 | SS | ARAVA | LEFLUNOMIDE | 1 | Unknown | 20 MG, QD | 0 | 20 | MG | TABLET | QD | ||||||
| 125308641 | 12530864 | 3 | SS | SULFASALAZINE. | SULFASALAZINE | 1 | Oral | 2 G, QD | 0 | 2 | G | QD | |||||||
| 125308641 | 12530864 | 4 | SS | SULFASALAZINE. | SULFASALAZINE | 1 | Oral | 2 G, QD | 0 | 2 | G | QD | |||||||
| 125308641 | 12530864 | 5 | SS | METHOTREXATE. | METHOTREXATE | 1 | Unknown | 20 MG, QWK | 0 | 20 | MG | /wk | |||||||
| 125308641 | 12530864 | 6 | SS | METHOTREXATE. | METHOTREXATE | 1 | Oral | UNK | 0 | ||||||||||
| 125308641 | 12530864 | 7 | SS | METHOTREXATE. | METHOTREXATE | 1 | Subcutaneous | UNK | 0 | ||||||||||
| 125308641 | 12530864 | 8 | SS | ACTEMRA | TOCILIZUMAB | 1 | Unknown | UNK | 0 | ||||||||||
| 125308641 | 12530864 | 9 | SS | HUMIRA | ADALIMUMAB | 1 | Unknown | UNK | 0 | ||||||||||
| 125308641 | 12530864 | 10 | SS | ORENCIA | ABATACEPT | 1 | Unknown | UNK | 0 | ||||||||||
| 125308641 | 12530864 | 11 | SS | REMICADE | INFLIXIMAB | 1 | Unknown | UNK | 0 | ||||||||||
| 125308641 | 12530864 | 12 | SS | CIMZIA | CERTOLIZUMAB PEGOL | 1 | Unknown | UNK | 0 | ||||||||||
| 125308641 | 12530864 | 13 | SS | SIMPONI | GOLIMUMAB | 1 | Unknown | UNK | 0 | ||||||||||
| 125308641 | 12530864 | 14 | SS | RITUXAN | RITUXIMAB | 1 | Unknown | UNK | 0 | ||||||||||
| 125308641 | 12530864 | 15 | C | PLAQUENIL /00072602/ | HYDROXYCHLOROQUINE DIPHOSPHATE | 1 | UNK | 0 | |||||||||||
| 125308641 | 12530864 | 16 | C | GOLD | GOLD | 1 | UNK | 0 | INJECTION |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125308641 | 12530864 | 1 | Rheumatoid arthritis |
| 125308641 | 12530864 | 2 | Rheumatoid arthritis |
| 125308641 | 12530864 | 3 | Rheumatoid arthritis |
| 125308641 | 12530864 | 5 | Rheumatoid arthritis |
| 125308641 | 12530864 | 8 | Product used for unknown indication |
| 125308641 | 12530864 | 9 | Product used for unknown indication |
| 125308641 | 12530864 | 10 | Product used for unknown indication |
| 125308641 | 12530864 | 11 | Product used for unknown indication |
| 125308641 | 12530864 | 12 | Product used for unknown indication |
| 125308641 | 12530864 | 13 | Product used for unknown indication |
| 125308641 | 12530864 | 14 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125308641 | 12530864 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125308641 | 12530864 | Ankle fracture | |
| 125308641 | 12530864 | Decreased appetite | |
| 125308641 | 12530864 | Drug effect incomplete | |
| 125308641 | 12530864 | Drug ineffective | |
| 125308641 | 12530864 | Headache | |
| 125308641 | 12530864 | Hypercholesterolaemia | |
| 125308641 | 12530864 | Infection | |
| 125308641 | 12530864 | Joint swelling | |
| 125308641 | 12530864 | Malaise | |
| 125308641 | 12530864 | Nausea | |
| 125308641 | 12530864 | Rheumatoid arthritis | |
| 125308641 | 12530864 | Stress | |
| 125308641 | 12530864 | Unevaluable event | |
| 125308641 | 12530864 | Vomiting |
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 |
|---|---|---|---|---|---|---|
| 125308641 | 12530864 | 2 | 200404 | 200604 | 0 | |
| 125308641 | 12530864 | 3 | 2001 | 2003 | 0 | |
| 125308641 | 12530864 | 4 | 2004 | 2004 | 0 | |
| 125308641 | 12530864 | 5 | 1997 | 200707 | 0 |