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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127877361 | 12787736 | 1 | I | 2002 | 20160914 | 20160928 | 20160928 | EXP | CA-ORION CORPORATION ORION PHARMA-TREX2016-1813 | ORION | 28.00 | YR | F | Y | 0.00000 | 20160928 | MD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127877361 | 12787736 | 1 | PS | METHOTREXATE (TRADE NAME UNKNOWN) | METHOTREXATE | 1 | Unknown | 0 | |||||||||||
| 127877361 | 12787736 | 2 | SS | ENBREL | ETANERCEPT | 1 | Unknown | 0 | 50 | MG | SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE | BIW | |||||||
| 127877361 | 12787736 | 3 | SS | PREDNISONE. | PREDNISONE | 1 | Unknown | U | 0 | ||||||||||
| 127877361 | 12787736 | 4 | SS | HUMIRA | ADALIMUMAB | 1 | Unknown | U | 0 | ||||||||||
| 127877361 | 12787736 | 5 | SS | ENBREL | ETANERCEPT | 1 | Unknown | U | 0 | 25 | MG | SOLUTION FOR INJECTION IN PRE-FILLED PEN | BIW | ||||||
| 127877361 | 12787736 | 6 | SS | ENBREL | ETANERCEPT | 1 | Unknown | U | 0 | SOLUTION FOR INJECTION IN PRE-FILLED PEN | |||||||||
| 127877361 | 12787736 | 7 | C | FOLIC ACID. | FOLIC ACID | 1 | Unknown | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127877361 | 12787736 | 2 | Rheumatoid arthritis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127877361 | 12787736 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127877361 | 12787736 | Arthralgia | |
| 127877361 | 12787736 | Arthropathy | |
| 127877361 | 12787736 | Chest discomfort | |
| 127877361 | 12787736 | Fatigue | |
| 127877361 | 12787736 | Foot fracture | |
| 127877361 | 12787736 | Frustration tolerance decreased | |
| 127877361 | 12787736 | Hypoaesthesia | |
| 127877361 | 12787736 | Irritability | |
| 127877361 | 12787736 | Joint range of motion decreased | |
| 127877361 | 12787736 | Joint stiffness | |
| 127877361 | 12787736 | Joint swelling | |
| 127877361 | 12787736 | Joint warmth | |
| 127877361 | 12787736 | Malaise | |
| 127877361 | 12787736 | Mood altered | |
| 127877361 | 12787736 | Nasal congestion | |
| 127877361 | 12787736 | Nausea | |
| 127877361 | 12787736 | Nephrolithiasis | |
| 127877361 | 12787736 | Neuropathy peripheral | |
| 127877361 | 12787736 | Osteopenia | |
| 127877361 | 12787736 | Pain | |
| 127877361 | 12787736 | Pain in extremity | |
| 127877361 | 12787736 | Paraesthesia | |
| 127877361 | 12787736 | Sinusitis | |
| 127877361 | 12787736 | Synovial disorder | |
| 127877361 | 12787736 | Upper respiratory tract infection | |
| 127877361 | 12787736 | Weight increased |
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 |
|---|---|---|---|---|---|---|
| 127877361 | 12787736 | 1 | 2002 | 0 | ||
| 127877361 | 12787736 | 2 | 20020101 | 2002 | 0 | |
| 127877361 | 12787736 | 3 | 2004 | 0 | ||
| 127877361 | 12787736 | 4 | 2003 | 0 | ||
| 127877361 | 12787736 | 5 | 2002 | 2003 | 0 | |
| 127877361 | 12787736 | 6 | 2004 | 0 |