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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 97651823 | 9765182 | 3 | F | 20130304 | 20160727 | 20131217 | 20160804 | EXP | DE-JNJFOC-20131205393 | JANSSEN | 50.00 | YR | A | F | Y | 0.00000 | 20160804 | MD | DE | DE |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 97651823 | 9765182 | 1 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | Y | N | 0 | 200 | MG | LYOPHILIZED POWDER | ||||||
| 97651823 | 9765182 | 2 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | Y | N | 0 | 300 | MG | LYOPHILIZED POWDER | ||||||
| 97651823 | 9765182 | 3 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | Y | N | 0 | 300 | MG | LYOPHILIZED POWDER | ||||||
| 97651823 | 9765182 | 4 | PS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | Y | N | 103772 | 300 | MG | LYOPHILIZED POWDER | ||||||
| 97651823 | 9765182 | 5 | SS | SULFASALAZINE DELAYED-RELEASE | SULFASALAZINE | 1 | Unknown | 0 | 1000 | MG | UNSPECIFIED | QID | |||||||
| 97651823 | 9765182 | 6 | SS | SULFASALAZINE DELAYED-RELEASE | SULFASALAZINE | 1 | Unknown | 0 | 1500 | MG | UNSPECIFIED | QID | |||||||
| 97651823 | 9765182 | 7 | SS | SULFASALAZINE DELAYED-RELEASE | SULFASALAZINE | 1 | Unknown | 0 | 1000 | MG | UNSPECIFIED | QID | |||||||
| 97651823 | 9765182 | 8 | SS | SULFASALAZINE DELAYED-RELEASE | SULFASALAZINE | 1 | Unknown | 0 | 2000 | MG | UNSPECIFIED | QID | |||||||
| 97651823 | 9765182 | 9 | SS | TOCILIZUMAB | TOCILIZUMAB | 1 | Unknown | 0 | |||||||||||
| 97651823 | 9765182 | 10 | C | PREDNISOLONE. | PREDNISOLONE | 1 | Unknown | 0 | 5 | MG | UNSPECIFIED | ||||||||
| 97651823 | 9765182 | 11 | C | VITAMIN D | CHOLECALCIFEROL | 1 | Unknown | 1000 | 0 | UNSPECIFIED |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 97651823 | 9765182 | 1 | Rheumatoid arthritis |
| 97651823 | 9765182 | 2 | Rheumatoid arthritis |
| 97651823 | 9765182 | 3 | Rheumatoid arthritis |
| 97651823 | 9765182 | 4 | Rheumatoid arthritis |
| 97651823 | 9765182 | 5 | Rheumatoid arthritis |
| 97651823 | 9765182 | 6 | Rheumatoid arthritis |
| 97651823 | 9765182 | 7 | Rheumatoid arthritis |
| 97651823 | 9765182 | 8 | Rheumatoid arthritis |
| 97651823 | 9765182 | 9 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 97651823 | 9765182 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 97651823 | 9765182 | Anaphylactic shock | |
| 97651823 | 9765182 | Bronchiolitis | |
| 97651823 | 9765182 | Foot operation | |
| 97651823 | 9765182 | Infusion related reaction |
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 |
|---|---|---|---|---|---|---|
| 97651823 | 9765182 | 1 | 200904 | 0 | ||
| 97651823 | 9765182 | 2 | 201302 | 0 | ||
| 97651823 | 9765182 | 3 | 201206 | 0 | ||
| 97651823 | 9765182 | 4 | 20130304 | 20130304 | 0 | |
| 97651823 | 9765182 | 5 | 20141113 | 20151022 | 0 | |
| 97651823 | 9765182 | 6 | 20101129 | 20141013 | 0 | |
| 97651823 | 9765182 | 7 | 20091026 | 20101129 | 0 | |
| 97651823 | 9765182 | 8 | 20151022 | 0 | ||
| 97651823 | 9765182 | 9 | 201208 | 201302 | 0 | |
| 97651823 | 9765182 | 10 | 2005 | 0 | ||
| 97651823 | 9765182 | 11 | 2005 | 0 |