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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126004091 | 12600409 | 1 | I | 20160719 | 20160727 | 20160727 | EXP | ES-JNJFOC-20160718054 | JANSSEN | FERRIT MM, GARCIA MO, SALADANA SR, GUTIERREZ CM, GARCIA LM, DEL MORAL C, ET AL. ADVERSE REACTIONS TO DRUGS ANTI-TUMOR NECROSIS FACTOR ALPHA: EVIDENCE IN REALCLINICAL PRACTICE. BASIC CLIN PHARMACOL TOXICOL 2015;117 (SUPPL 2):40. | 0.00 | Y | 0.00000 | 20160727 | OT | ES | ES |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126004091 | 12600409 | 1 | SS | INFLIXIMAB, RECOMBINANT | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | U | U | 0 | LYOPHILIZED POWDER | ||||||||
| 126004091 | 12600409 | 2 | PS | INFLIXIMAB, RECOMBINANT | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | U | U | 103772 | LYOPHILIZED POWDER | ||||||||
| 126004091 | 12600409 | 3 | SS | SIMPONI | GOLIMUMAB | 1 | Subcutaneous | U | U | 0 | SOLUTION FOR INJECTION | ||||||||
| 126004091 | 12600409 | 4 | SS | SIMPONI | GOLIMUMAB | 1 | Subcutaneous | U | U | 125289 | SOLUTION FOR INJECTION |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126004091 | 12600409 | 1 | Rheumatoid arthritis |
| 126004091 | 12600409 | 2 | Ankylosing spondylitis |
| 126004091 | 12600409 | 3 | Ankylosing spondylitis |
| 126004091 | 12600409 | 4 | Rheumatoid arthritis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126004091 | 12600409 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126004091 | 12600409 | Blood disorder | |
| 126004091 | 12600409 | Cardiovascular disorder | |
| 126004091 | 12600409 | Drug intolerance | |
| 126004091 | 12600409 | Gastrointestinal disorder | |
| 126004091 | 12600409 | Hospitalisation | |
| 126004091 | 12600409 | Infection | |
| 126004091 | 12600409 | Malaise | |
| 126004091 | 12600409 | Skin disorder | |
| 126004091 | 12600409 | Uveitis |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |