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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 116078418 | 11607841 | 8 | F | 20160810 | 20151007 | 20160824 | EXP | CA-JNJFOC-20150923280 | JANSSEN | 43.00 | YR | A | F | Y | 0.00000 | 20160824 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 116078418 | 11607841 | 1 | PS | SIMPONI | GOLIMUMAB | 1 | Subcutaneous | Y | U | UNKNOWN;UNKNOWN | 125289 | SOLUTION FOR INJECTION | |||||||
| 116078418 | 11607841 | 2 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | Y | U | UNKNOWN;UNKNOWN | 103772 | LYOPHILIZED POWDER | |||||||
| 116078418 | 11607841 | 3 | SS | METHOTREXATE. | METHOTREXATE | 1 | Unknown | U | 0 | UNSPECIFIED | |||||||||
| 116078418 | 11607841 | 4 | SS | FOLIC ACID. | FOLIC ACID | 1 | Unknown | U | 0 | 1 | MG | UNSPECIFIED | |||||||
| 116078418 | 11607841 | 5 | SS | REACTINE | CETIRIZINE HYDROCHLORIDE | 1 | Unknown | U | 0 | UNSPECIFIED | |||||||||
| 116078418 | 11607841 | 6 | SS | ACTEMRA | TOCILIZUMAB | 1 | Unknown | U | 0 | UNSPECIFIED | |||||||||
| 116078418 | 11607841 | 7 | SS | ARAVA | LEFLUNOMIDE | 1 | Oral | U | 0 | TABLET | |||||||||
| 116078418 | 11607841 | 8 | SS | CIMZIA | CERTOLIZUMAB PEGOL | 1 | Subcutaneous | Y | 0 | SOLUTION | |||||||||
| 116078418 | 11607841 | 9 | SS | ENBREL | ETANERCEPT | 1 | Subcutaneous | Y | 0 | SOLUTION | |||||||||
| 116078418 | 11607841 | 10 | SS | PREDNISONE. | PREDNISONE | 1 | Unknown | U | 0 | TABLET | |||||||||
| 116078418 | 11607841 | 11 | SS | HUMIRA | ADALIMUMAB | 1 | Subcutaneous | Y | 0 | SOLUTION | |||||||||
| 116078418 | 11607841 | 12 | SS | ORENCIA | ABATACEPT | 1 | Intravenous (not otherwise specified) | U | 0 | UNSPECIFIED | |||||||||
| 116078418 | 11607841 | 13 | SS | FOSAMAX | ALENDRONATE SODIUM | 1 | Oral | U | 0 | TABLET | |||||||||
| 116078418 | 11607841 | 14 | SS | PLAQUENIL | HYDROXYCHLOROQUINE SULFATE | 1 | Unknown | Y | 0 | TABLET | |||||||||
| 116078418 | 11607841 | 15 | SS | RITUXAN | RITUXIMAB | 1 | Intravenous (not otherwise specified) | Y | 0 | SOLUTION | |||||||||
| 116078418 | 11607841 | 16 | SS | PHTHALYLSULFATHIAZOLE | PHTHALYLSULFATHIAZOLE | 1 | Unknown | U | 0 | UNSPECIFIED | |||||||||
| 116078418 | 11607841 | 17 | SS | SULFASALAZINE. | SULFASALAZINE | 1 | Unknown | Y | 0 | UNSPECIFIED | |||||||||
| 116078418 | 11607841 | 18 | SS | ZYRTEC | CETIRIZINE HYDROCHLORIDE | 1 | Unknown | U | 0 | 10 | MG | TABLET | |||||||
| 116078418 | 11607841 | 19 | SS | CORTISONE | CORTISONEHYDROCORTISONE | 1 | Oral | U | 0 | UNSPECIFIED | |||||||||
| 116078418 | 11607841 | 20 | SS | CORTISONE ACETATE. | CORTISONE ACETATE | 1 | Unknown | U | 0 | 25 | MG | UNSPECIFIED |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 116078418 | 11607841 | 1 | Rheumatoid arthritis |
| 116078418 | 11607841 | 2 | Rheumatoid arthritis |
| 116078418 | 11607841 | 3 | Rheumatoid arthritis |
| 116078418 | 11607841 | 4 | Rheumatoid arthritis |
| 116078418 | 11607841 | 5 | Rheumatoid arthritis |
| 116078418 | 11607841 | 6 | Rheumatoid arthritis |
| 116078418 | 11607841 | 7 | Rheumatoid arthritis |
| 116078418 | 11607841 | 8 | Rheumatoid arthritis |
| 116078418 | 11607841 | 9 | Rheumatoid arthritis |
| 116078418 | 11607841 | 10 | Rheumatoid arthritis |
| 116078418 | 11607841 | 11 | Rheumatoid arthritis |
| 116078418 | 11607841 | 12 | Rheumatoid arthritis |
| 116078418 | 11607841 | 13 | Rheumatoid arthritis |
| 116078418 | 11607841 | 14 | Rheumatoid arthritis |
| 116078418 | 11607841 | 15 | Rheumatoid arthritis |
| 116078418 | 11607841 | 16 | Rheumatoid arthritis |
| 116078418 | 11607841 | 17 | Rheumatoid arthritis |
| 116078418 | 11607841 | 18 | Product used for unknown indication |
| 116078418 | 11607841 | 19 | Rheumatoid arthritis |
| 116078418 | 11607841 | 20 | Rheumatoid arthritis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 116078418 | 11607841 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 116078418 | 11607841 | Abdominal discomfort | |
| 116078418 | 11607841 | Alopecia | |
| 116078418 | 11607841 | Drug ineffective | |
| 116078418 | 11607841 | Exposure during pregnancy | |
| 116078418 | 11607841 | Fatigue | |
| 116078418 | 11607841 | Glossodynia | |
| 116078418 | 11607841 | Hand deformity | |
| 116078418 | 11607841 | Hip arthroplasty | |
| 116078418 | 11607841 | Knee arthroplasty | |
| 116078418 | 11607841 | Pain | |
| 116078418 | 11607841 | Pemphigus | |
| 116078418 | 11607841 | Rheumatoid arthritis | |
| 116078418 | 11607841 | Swelling | |
| 116078418 | 11607841 | Systemic lupus erythematosus | |
| 116078418 | 11607841 | Wound |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |