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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123378192 | 12337819 | 2 | F | 20160818 | 20160505 | 20160824 | EXP | CA-AMGEN-CANSP2016055349 | AMGEN | 0.00 | M | Y | 0.00000 | 20160824 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123378192 | 12337819 | 1 | PS | ENBREL | ETANERCEPT | 1 | Unknown | UNK | U | 103795 | UNKNOWN FORMULATION | ||||||||
| 123378192 | 12337819 | 2 | SS | ENBREL | ETANERCEPT | 1 | U | 103795 | UNKNOWN FORMULATION | ||||||||||
| 123378192 | 12337819 | 3 | SS | ACTEMRA | TOCILIZUMAB | 1 | Unknown | UNK | 0 | ||||||||||
| 123378192 | 12337819 | 4 | SS | ACTEMRA | TOCILIZUMAB | 1 | 0 | ||||||||||||
| 123378192 | 12337819 | 5 | SS | ANAKINRA | ANAKINRA | 1 | Unknown | UNK | 0 | ||||||||||
| 123378192 | 12337819 | 6 | SS | ANAKINRA | ANAKINRA | 1 | 0 | ||||||||||||
| 123378192 | 12337819 | 7 | SS | GOLD | GOLD | 1 | Unknown | UNK | 0 | ||||||||||
| 123378192 | 12337819 | 8 | SS | HUMIRA | ADALIMUMAB | 1 | Subcutaneous | UNK | 0 | ||||||||||
| 123378192 | 12337819 | 9 | SS | HUMIRA | ADALIMUMAB | 1 | 0 | ||||||||||||
| 123378192 | 12337819 | 10 | SS | HYDROXYCHLOROQUINE SULFATE. | HYDROXYCHLOROQUINE SULFATE | 1 | Unknown | UNK | 0 | ||||||||||
| 123378192 | 12337819 | 11 | SS | HYDROXYCHLOROQUINE SULFATE. | HYDROXYCHLOROQUINE SULFATE | 1 | 0 | ||||||||||||
| 123378192 | 12337819 | 12 | SS | ILARIS | CANAKINUMAB | 1 | Subcutaneous | UNK | 0 | POWDER FOR SOLUTION FOR INJECTION | |||||||||
| 123378192 | 12337819 | 13 | SS | ILARIS | CANAKINUMAB | 1 | Unknown | UNK | 0 | POWDER FOR SOLUTION FOR INJECTION | |||||||||
| 123378192 | 12337819 | 14 | SS | LEFLUNOMIDE. | LEFLUNOMIDE | 1 | Unknown | UNK | 0 | TABLET | |||||||||
| 123378192 | 12337819 | 15 | SS | LEFLUNOMIDE. | LEFLUNOMIDE | 1 | 0 | TABLET | |||||||||||
| 123378192 | 12337819 | 16 | SS | METHOTREXATE. | METHOTREXATE | 1 | Unknown | UNK | 0 | ||||||||||
| 123378192 | 12337819 | 17 | SS | METHOTREXATE. | METHOTREXATE | 1 | 0 | ||||||||||||
| 123378192 | 12337819 | 18 | SS | ORENCIA | ABATACEPT | 1 | Intravenous (not otherwise specified) | UNK | 0 | POWDER FOR SOLUTION FOR INFUSION | |||||||||
| 123378192 | 12337819 | 19 | SS | ORENCIA | ABATACEPT | 1 | 0 | POWDER FOR SOLUTION FOR INFUSION | |||||||||||
| 123378192 | 12337819 | 20 | SS | PLAQUENIL /00072602/ | HYDROXYCHLOROQUINE DIPHOSPHATE | 1 | Unknown | UNK | 0 | TABLET | |||||||||
| 123378192 | 12337819 | 21 | SS | PLAQUENIL /00072602/ | HYDROXYCHLOROQUINE DIPHOSPHATE | 1 | 0 | TABLET | |||||||||||
| 123378192 | 12337819 | 22 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | 0 | POWDER FOR SOLUTION FOR INFUSION | ||||||||||
| 123378192 | 12337819 | 23 | SS | REMICADE | INFLIXIMAB | 1 | 0 | POWDER FOR SOLUTION FOR INFUSION | |||||||||||
| 123378192 | 12337819 | 24 | SS | RITUXAN | RITUXIMAB | 1 | Intravenous (not otherwise specified) | UNK | 0 | ||||||||||
| 123378192 | 12337819 | 25 | SS | RITUXAN | RITUXIMAB | 1 | 0 | ||||||||||||
| 123378192 | 12337819 | 26 | SS | SULFASALAZINE. | SULFASALAZINE | 1 | Unknown | UNK | 0 | ||||||||||
| 123378192 | 12337819 | 27 | SS | SULFASALAZINE. | SULFASALAZINE | 1 | 0 | ||||||||||||
| 123378192 | 12337819 | 28 | SS | HYDROXYCHLOROQUINE | HYDROXYCHLOROQUINE | 1 | Unknown | UNK | 0 | TABLET | |||||||||
| 123378192 | 12337819 | 29 | SS | HYDROXYCHLOROQUINE | HYDROXYCHLOROQUINE | 1 | 0 | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 123378192 | 12337819 | 1 | Systemic lupus erythematosus |
| 123378192 | 12337819 | 2 | Rheumatoid arthritis |
| 123378192 | 12337819 | 3 | Systemic lupus erythematosus |
| 123378192 | 12337819 | 4 | Rheumatoid arthritis |
| 123378192 | 12337819 | 5 | Systemic lupus erythematosus |
| 123378192 | 12337819 | 6 | Rheumatoid arthritis |
| 123378192 | 12337819 | 7 | Rheumatoid arthritis |
| 123378192 | 12337819 | 8 | Systemic lupus erythematosus |
| 123378192 | 12337819 | 9 | Rheumatoid arthritis |
| 123378192 | 12337819 | 10 | Systemic lupus erythematosus |
| 123378192 | 12337819 | 11 | Rheumatoid arthritis |
| 123378192 | 12337819 | 12 | Systemic lupus erythematosus |
| 123378192 | 12337819 | 13 | Rheumatoid arthritis |
| 123378192 | 12337819 | 14 | Systemic lupus erythematosus |
| 123378192 | 12337819 | 15 | Rheumatoid arthritis |
| 123378192 | 12337819 | 16 | Systemic lupus erythematosus |
| 123378192 | 12337819 | 17 | Rheumatoid arthritis |
| 123378192 | 12337819 | 18 | Rheumatoid arthritis |
| 123378192 | 12337819 | 19 | Systemic lupus erythematosus |
| 123378192 | 12337819 | 20 | Systemic lupus erythematosus |
| 123378192 | 12337819 | 21 | Rheumatoid arthritis |
| 123378192 | 12337819 | 22 | Systemic lupus erythematosus |
| 123378192 | 12337819 | 23 | Rheumatoid arthritis |
| 123378192 | 12337819 | 24 | Systemic lupus erythematosus |
| 123378192 | 12337819 | 25 | Rheumatoid arthritis |
| 123378192 | 12337819 | 26 | Rheumatoid arthritis |
| 123378192 | 12337819 | 27 | Systemic lupus erythematosus |
| 123378192 | 12337819 | 28 | Systemic lupus erythematosus |
| 123378192 | 12337819 | 29 | Rheumatoid arthritis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 123378192 | 12337819 | OT |
| 123378192 | 12337819 | LT |
| 123378192 | 12337819 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 123378192 | 12337819 | Apparent death | |
| 123378192 | 12337819 | Deep vein thrombosis | |
| 123378192 | 12337819 | Diverticulitis | |
| 123378192 | 12337819 | Drug ineffective | |
| 123378192 | 12337819 | Joint swelling | |
| 123378192 | 12337819 | Off label use | |
| 123378192 | 12337819 | Pain | |
| 123378192 | 12337819 | Pulmonary embolism | |
| 123378192 | 12337819 | Renal failure |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |