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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124307853 | 12430785 | 3 | F | 2014 | 20160914 | 20160602 | 20160921 | EXP | US-AMGEN-USASP2016069196 | AMGEN | 77.00 | YR | E | M | Y | 72.57000 | KG | 20160920 | MD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124307853 | 12430785 | 1 | PS | ENBREL | ETANERCEPT | 1 | Unknown | UNK | U | 103795 | UNKNOWN FORMULATION | ||||||||
| 124307853 | 12430785 | 2 | SS | ORENCIA | ABATACEPT | 1 | Unknown | UNK | 0 | ||||||||||
| 124307853 | 12430785 | 3 | SS | XELJANZ | TOFACITINIB CITRATE | 1 | Oral | 11 MG ONE TABLET, QD | 0 | 11 | MG | QD | |||||||
| 124307853 | 12430785 | 4 | SS | METHOTREXATE. | METHOTREXATE | 1 | Unknown | UNK | 0 | ||||||||||
| 124307853 | 12430785 | 5 | SS | METHOTREXATE. | METHOTREXATE | 1 | Oral | 17.5 MG, QWK | 0 | 17.5 | MG | /wk | |||||||
| 124307853 | 12430785 | 6 | SS | METHOTREXATE. | METHOTREXATE | 1 | Unknown | 2.5 MG, QWK | 0 | 2.5 | MG | /wk | |||||||
| 124307853 | 12430785 | 7 | SS | PLAQUENIL | HYDROXYCHLOROQUINE SULFATE | 1 | Unknown | UNK | 0 | ||||||||||
| 124307853 | 12430785 | 8 | SS | HUMIRA | ADALIMUMAB | 1 | Unknown | UNK | 0 | ||||||||||
| 124307853 | 12430785 | 9 | SS | REMICADE | INFLIXIMAB | 1 | Unknown | 100 MG, UNK | 0 | 100 | MG | ||||||||
| 124307853 | 12430785 | 10 | SS | REMICADE | INFLIXIMAB | 1 | Unknown | 700 MG, UNK | 0 | 700 | MG | ||||||||
| 124307853 | 12430785 | 11 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | 700 UNK, UNK | 0 | 700 | MG | ||||||||
| 124307853 | 12430785 | 12 | C | COUMADIN | WARFARIN SODIUM | 1 | 3 MG, QD | 0 | 3 | MG | QD | ||||||||
| 124307853 | 12430785 | 13 | C | SOTALOL. | SOTALOL | 1 | 80 MG, ONE HALF TABLET TID | 0 | 80 | MG | TABLET | TID | |||||||
| 124307853 | 12430785 | 14 | C | PREDNISONE. | PREDNISONE | 1 | 10 MG, AS NECESSARY | 0 | 10 | MG | |||||||||
| 124307853 | 12430785 | 15 | C | FOLIC ACID. | FOLIC ACID | 1 | 1 MG, QWK | 0 | 1 | MG | /wk | ||||||||
| 124307853 | 12430785 | 16 | C | TYLENOL | ACETAMINOPHEN | 1 | UNK UNK, AS NECESSARY | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124307853 | 12430785 | 1 | Rheumatoid arthritis |
| 124307853 | 12430785 | 2 | Rheumatoid arthritis |
| 124307853 | 12430785 | 3 | Rheumatoid arthritis |
| 124307853 | 12430785 | 4 | Rheumatoid arthritis |
| 124307853 | 12430785 | 7 | Rheumatoid arthritis |
| 124307853 | 12430785 | 8 | Rheumatoid arthritis |
| 124307853 | 12430785 | 9 | Rheumatoid arthritis |
| 124307853 | 12430785 | 12 | Aortic valve disease |
| 124307853 | 12430785 | 13 | Heart rate irregular |
| 124307853 | 12430785 | 14 | Arthritis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124307853 | 12430785 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124307853 | 12430785 | Atrial fibrillation | |
| 124307853 | 12430785 | Drug effect delayed | |
| 124307853 | 12430785 | Nervous system disorder | |
| 124307853 | 12430785 | Peripheral swelling | |
| 124307853 | 12430785 | Rheumatoid arthritis | |
| 124307853 | 12430785 | Sleep apnoea syndrome | |
| 124307853 | 12430785 | Vertigo |
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 |
|---|---|---|---|---|---|---|
| 124307853 | 12430785 | 2 | 201510 | 201605 | 0 | |
| 124307853 | 12430785 | 14 | 20160101 | 0 |