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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127146461 | 12714646 | 1 | I | 20160824 | 20160905 | 20160905 | EXP | DE-JNJFOC-20160822547 | JANSSEN | WINKELMANN J, ZEUNER RA, SCHULDT D, BETHGE J, MROWIETZ U, LAUDES M, ET AL. INCIDENCE OF CLINICAL AND SEROLOGICAL LUPUS-LIKE DISEASE DURING ANTI-TNFALPHA-TREATMENT-A TWO-YEAR PROSPECTIVE STUDY IN AN INTERDISCIPLINARY PATIENT COHORT. ARTHRITIS AND RHEUMATOLOGY 2014;66 ():S208. | 0.00 | Y | 0.00000 | 20160905 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127146461 | 12714646 | 1 | SS | INFLIXIMAB, RECOMBINANT | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | 0 | LYOPHILIZED POWDER | |||||||||
| 127146461 | 12714646 | 2 | SS | INFLIXIMAB, RECOMBINANT | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | 0 | LYOPHILIZED POWDER | |||||||||
| 127146461 | 12714646 | 3 | SS | INFLIXIMAB, RECOMBINANT | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | 0 | LYOPHILIZED POWDER | |||||||||
| 127146461 | 12714646 | 4 | PS | INFLIXIMAB, RECOMBINANT | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | 103772 | LYOPHILIZED POWDER | |||||||||
| 127146461 | 12714646 | 5 | C | METHOTREXATE. | METHOTREXATE | 1 | Unknown | 0 | UNKNOWN |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127146461 | 12714646 | 1 | Juvenile idiopathic arthritis |
| 127146461 | 12714646 | 2 | Inflammatory bowel disease |
| 127146461 | 12714646 | 3 | Rheumatoid arthritis |
| 127146461 | 12714646 | 4 | Spondyloarthropathy |
| 127146461 | 12714646 | 5 | Rheumatic disorder |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127146461 | 12714646 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127146461 | 12714646 | Antinuclear antibody positive | |
| 127146461 | 12714646 | Double stranded DNA antibody | |
| 127146461 | 12714646 | Lupus-like syndrome | |
| 127146461 | 12714646 | Seroconversion test positive |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |