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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 115917565 | 11591756 | 5 | F | 20160826 | 20151005 | 20160829 | EXP | CA-ROCHE-1640193 | ROCHE | 0.00 | F | Y | 0.00000 | 20160829 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 115917565 | 11591756 | 1 | PS | ACTEMRA | TOCILIZUMAB | 1 | Intravenous (not otherwise specified) | N | 125276 | 800 | MG | SOLUTION FOR INFUSION | |||||||
| 115917565 | 11591756 | 2 | SS | CELEBREX | CELECOXIB | 1 | Unknown | N | 0 | CAPSULE | |||||||||
| 115917565 | 11591756 | 3 | SS | ASPIRIN. | ASPIRIN | 1 | Unknown | N | 0 | ||||||||||
| 115917565 | 11591756 | 4 | SS | METHOTREXATE. | METHOTREXATE | 1 | Unknown | N | 0 | 25 | MG | /wk | |||||||
| 115917565 | 11591756 | 5 | SS | HUMIRA | ADALIMUMAB | 1 | Subcutaneous | N | 0 | 40 | MG | QOW | |||||||
| 115917565 | 11591756 | 6 | SS | ENBREL | ETANERCEPT | 1 | Subcutaneous | N | 0 | 50 | MG | /wk | |||||||
| 115917565 | 11591756 | 7 | SS | SIMPONI | GOLIMUMAB | 1 | Unknown | N | 0 | 50 | MG | /month | |||||||
| 115917565 | 11591756 | 8 | SS | LEFLUNOMIDE. | LEFLUNOMIDE | 1 | Unknown | N | 0 | 20 | MG | QD | |||||||
| 115917565 | 11591756 | 9 | C | XELJANZ | TOFACITINIB CITRATE | 1 | Unknown | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 115917565 | 11591756 | 1 | Rheumatoid arthritis |
| 115917565 | 11591756 | 2 | Rheumatoid arthritis |
| 115917565 | 11591756 | 3 | Product used for unknown indication |
| 115917565 | 11591756 | 4 | Rheumatoid arthritis |
| 115917565 | 11591756 | 5 | Rheumatoid arthritis |
| 115917565 | 11591756 | 6 | Rheumatoid arthritis |
| 115917565 | 11591756 | 7 | Rheumatoid arthritis |
| 115917565 | 11591756 | 8 | Rheumatoid arthritis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 115917565 | 11591756 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 115917565 | 11591756 | Condition aggravated | |
| 115917565 | 11591756 | Drug effect incomplete | |
| 115917565 | 11591756 | Drug hypersensitivity | |
| 115917565 | 11591756 | Drug ineffective | |
| 115917565 | 11591756 | Pharyngeal oedema | |
| 115917565 | 11591756 | Rheumatoid arthritis | |
| 115917565 | 11591756 | Swelling face | |
| 115917565 | 11591756 | Swollen tongue |
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 |
|---|---|---|---|---|---|---|
| 115917565 | 11591756 | 1 | 201201 | 201507 | 0 | |
| 115917565 | 11591756 | 4 | 2009 | 0 | ||
| 115917565 | 11591756 | 5 | 201010 | 201012 | 0 | |
| 115917565 | 11591756 | 6 | 201107 | 201112 | 0 | |
| 115917565 | 11591756 | 7 | 201005 | 201009 | 0 | |
| 115917565 | 11591756 | 8 | 200912 | 201003 | 0 | |
| 115917565 | 11591756 | 9 | 20150823 | 0 |