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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 100080849 | 10008084 | 9 | F | 20140923 | 20140313 | 20140930 | EXP | US-JNJFOC-20140305009 | JANSSEN | SCHIFF M, DOUGADOS M, FLEISCHMANN R, FAY J, MALDONADO M. ABATACEPT AND ANTI-TUMOR NECROSIS FACTOR MONOCLONAL ANTIBODIES: EFFICACY AND SAFETY COMPARISONS. J. RHEUMATOL. 2014;41 (7):1473. SCHIFF M, DOUGADOS M, FLEISCHMANN R, FAY J, MALDONADO M. FRI0257 ABATACEPT AND ANTI-TNF MONOCLONAL ANTIBODIES: EFFICACY AND SAFETY COMPARISONS. ANNALS OF THE RHEUMATIC DISEASES 2013;72 (3):461. SCHIFF M, DOUGADOS M, FLEISCHMANN R, FAY J, MALDONADO M, ROY S. ABATACEPT AND ANTI-TNF MONOCLONAL ANTIBODIES: EFFICACY | 0.00 | Y | 0.00000 | 20140930 | N | OT | US | US |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 100080849 | 10008084 | 1 | PS | INFLIXIMAB, RECOMBINANT | INFLIXIMAB | 1 | INTRAVENOUS | U | 103772 | 3 | MG/KG | LYOPHILIZED POWDER | /wk | ||||||
| 100080849 | 10008084 | 2 | C | METHOTREXATE | METHOTREXATE | 1 | UNKNOWN | D | 0 | UNSPECIFIED |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 100080849 | 10008084 | 1 | Rheumatoid arthritis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 100080849 | 10008084 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 100080849 | 10008084 | Adverse event | |
| 100080849 | 10008084 | Autoimmune disorder | |
| 100080849 | 10008084 | Infection | |
| 100080849 | 10008084 | Neoplasm malignant | |
| 100080849 | 10008084 | Opportunistic infection |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |