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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124957533 | 12495753 | 3 | F | 20151030 | 20160627 | 20160624 | 20160705 | EXP | PHHY2016GB083282 | SANDOZ | 70.00 | YR | F | Y | 0.00000 | 20160705 | OT | GB | GB |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124957533 | 12495753 | 1 | PS | LEFLUNOMIDE. | LEFLUNOMIDE | 1 | Oral | 10 MG, UNK, FOUR TIMES A WEEK | Y | U | 77087 | 10 | MG | ||||||
| 124957533 | 12495753 | 2 | SS | LEFLUNOMIDE. | LEFLUNOMIDE | 1 | Oral | 10 MG, THREE TIMES A WEEK (ON MONDAYS, WEDNESDAYS AND FRIDAYS)) | Y | U | 77087 | 10 | MG | ||||||
| 124957533 | 12495753 | 3 | SS | ENBREL | ETANERCEPT | 1 | Subcutaneous | 50 MG, QW | 1071.72595 | MG | Y | U | 0 | 50 | MG | /wk | |||
| 124957533 | 12495753 | 4 | SS | ENBREL | ETANERCEPT | 1 | Subcutaneous | 50 MG, QW | 1071.72595 | MG | Y | U | 0 | 50 | MG | /wk | |||
| 124957533 | 12495753 | 5 | C | ADCAL | CALCIUM CARBONATE | 1 | Unknown | U | 0 | ||||||||||
| 124957533 | 12495753 | 6 | C | ADCAL | CALCIUM CARBONATE | 1 | U | 0 | |||||||||||
| 124957533 | 12495753 | 7 | C | CANDESARTAN | CANDESARTAN | 1 | Unknown | U | 0 | ||||||||||
| 124957533 | 12495753 | 8 | C | CANDESARTAN | CANDESARTAN | 1 | U | 0 | |||||||||||
| 124957533 | 12495753 | 9 | C | CELEBREX | CELECOXIB | 1 | Unknown | 100 MG BID, TWICE DAILY | U | 0 | 100 | MG | BID | ||||||
| 124957533 | 12495753 | 10 | C | CELEBREX | CELECOXIB | 1 | 100 MG, TWICE DAILY | U | 0 | 100 | MG | BID | |||||||
| 124957533 | 12495753 | 11 | C | DOXAZOSIN | DOXAZOSINDOXAZOSIN MESYLATE | 1 | Unknown | U | 0 | ||||||||||
| 124957533 | 12495753 | 12 | C | DOXAZOSIN | DOXAZOSINDOXAZOSIN MESYLATE | 1 | UNK | U | 0 | ||||||||||
| 124957533 | 12495753 | 13 | C | LANSOPRAZOLE. | LANSOPRAZOLE | 1 | Unknown | U | 0 | ||||||||||
| 124957533 | 12495753 | 14 | C | LANSOPRAZOLE. | LANSOPRAZOLE | 1 | UNK | U | 0 | ||||||||||
| 124957533 | 12495753 | 15 | C | PREDNISOLONE. | PREDNISOLONE | 1 | Unknown | 4 MG QD DAILY | U | 0 | 4 | MG | QD | ||||||
| 124957533 | 12495753 | 16 | C | PREDNISOLONE. | PREDNISOLONE | 1 | 4 MG, DAILY | U | 0 | 4 | MG | ||||||||
| 124957533 | 12495753 | 17 | C | TOLTERODINE | TOLTERODINE | 1 | Unknown | 4 MG QD DAILY | U | 0 | 4 | MG | QD | ||||||
| 124957533 | 12495753 | 18 | C | TOLTERODINE | TOLTERODINE | 1 | 4 MG, DAILY | U | 0 | 4 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124957533 | 12495753 | 1 | Rheumatoid arthritis |
| 124957533 | 12495753 | 3 | Rheumatoid arthritis |
| 124957533 | 12495753 | 5 | Osteopenia |
| 124957533 | 12495753 | 7 | Hypertension |
| 124957533 | 12495753 | 9 | Rheumatoid arthritis |
| 124957533 | 12495753 | 11 | Hypertension |
| 124957533 | 12495753 | 13 | Prophylaxis against gastrointestinal ulcer |
| 124957533 | 12495753 | 15 | Rheumatoid arthritis |
| 124957533 | 12495753 | 17 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124957533 | 12495753 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124957533 | 12495753 | Anxiety | |
| 124957533 | 12495753 | Atrial fibrillation | |
| 124957533 | 12495753 | Blood pressure increased | |
| 124957533 | 12495753 | Cardiac failure | |
| 124957533 | 12495753 | Diarrhoea | |
| 124957533 | 12495753 | Heart rate irregular | |
| 124957533 | 12495753 | Injection site rash | |
| 124957533 | 12495753 | Joint dislocation | |
| 124957533 | 12495753 | Osteoarthritis | |
| 124957533 | 12495753 | Pain | |
| 124957533 | 12495753 | Palpitations | |
| 124957533 | 12495753 | Rash | |
| 124957533 | 12495753 | Rheumatoid arthritis | |
| 124957533 | 12495753 | Sluggishness |
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 |
|---|---|---|---|---|---|---|
| 124957533 | 12495753 | 2 | 20141210 | 0 | ||
| 124957533 | 12495753 | 3 | 20150602 | 0 | ||
| 124957533 | 12495753 | 4 | 20150602 | 20160204 | 0 | |
| 124957533 | 12495753 | 5 | 2010 | 0 | ||
| 124957533 | 12495753 | 6 | 2010 | 0 | ||
| 124957533 | 12495753 | 7 | 2010 | 0 | ||
| 124957533 | 12495753 | 8 | 2010 | 0 | ||
| 124957533 | 12495753 | 9 | 1996 | 0 | ||
| 124957533 | 12495753 | 10 | 1996 | 0 | ||
| 124957533 | 12495753 | 11 | 2011 | 0 | ||
| 124957533 | 12495753 | 12 | 2011 | 0 | ||
| 124957533 | 12495753 | 13 | 2000 | 0 | ||
| 124957533 | 12495753 | 14 | 2000 | 0 | ||
| 124957533 | 12495753 | 15 | 199609 | 0 | ||
| 124957533 | 12495753 | 16 | 199609 | 0 |