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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 117324883 | 11732488 | 3 | F | 20160824 | 20151113 | 20160830 | EXP | CA-ROCHE-1656954 | ROCHE | 77.00 | YR | F | Y | 0.00000 | 20160830 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 117324883 | 11732488 | 1 | PS | RITUXAN | RITUXIMAB | 1 | Intravenous (not otherwise specified) | U | 103705 | 1000 | MG | SOLUTION FOR INFUSION | |||||||
| 117324883 | 11732488 | 2 | SS | ACTEMRA | TOCILIZUMAB | 1 | Subcutaneous | U | 125472 | 162 | MG | SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE | /wk | ||||||
| 117324883 | 11732488 | 3 | SS | ORENCIA | ABATACEPT | 1 | Intravenous (not otherwise specified) | 0 | 125 | MG | POWDER FOR INFUSION | /wk | |||||||
| 117324883 | 11732488 | 4 | SS | ENBREL | ETANERCEPT | 1 | Subcutaneous | U | 0 | 50 | MG | /wk | |||||||
| 117324883 | 11732488 | 5 | SS | HUMIRA | ADALIMUMAB | 1 | Subcutaneous | U | 0 | 40 | MG | QOW | |||||||
| 117324883 | 11732488 | 6 | C | ANAKINRA | ANAKINRA | 1 | 0 | ||||||||||||
| 117324883 | 11732488 | 7 | C | SULFASALAZINE. | SULFASALAZINE | 1 | 0 | ||||||||||||
| 117324883 | 11732488 | 8 | C | LEFLUNOMIDE. | LEFLUNOMIDE | 1 | Unknown | 0 | TABLET | ||||||||||
| 117324883 | 11732488 | 9 | C | IMURAN | AZATHIOPRINE | 1 | 0 | ||||||||||||
| 117324883 | 11732488 | 10 | C | METHOTREXATE. | METHOTREXATE | 1 | 0 | ||||||||||||
| 117324883 | 11732488 | 11 | C | MINOCYCLINE | MINOCYCLINEMINOCYCLINE HYDROCHLORIDE | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 117324883 | 11732488 | 1 | Rheumatoid arthritis |
| 117324883 | 11732488 | 2 | Rheumatoid arthritis |
| 117324883 | 11732488 | 3 | Product used for unknown indication |
| 117324883 | 11732488 | 4 | Product used for unknown indication |
| 117324883 | 11732488 | 5 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 117324883 | 11732488 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 117324883 | 11732488 | Arthralgia | |
| 117324883 | 11732488 | Crohn's disease | |
| 117324883 | 11732488 | Drug effect incomplete | |
| 117324883 | 11732488 | Drug ineffective | |
| 117324883 | 11732488 | Hypoacusis | |
| 117324883 | 11732488 | Infusion related reaction | |
| 117324883 | 11732488 | Joint swelling | |
| 117324883 | 11732488 | Rash |
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 |
|---|---|---|---|---|---|---|
| 117324883 | 11732488 | 1 | 2007 | 2014 | 0 | |
| 117324883 | 11732488 | 2 | 201506 | 201510 | 0 | |
| 117324883 | 11732488 | 3 | 201410 | 201504 | 0 |