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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124574472 | 12457447 | 2 | F | 201506 | 20160627 | 20160610 | 20160708 | EXP | GB-SA-2016SA105640 | AVENTIS | 70.00 | YR | E | F | Y | 0.00000 | 20160708 | CN | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124574472 | 12457447 | 1 | PS | LEFLUNOMIDE. | LEFLUNOMIDE | 1 | Oral | FREQUENCY: 10 MG (MONDAY, WEDNESDAY AND FRIDAY) | U | L76737 | 20905 | 10 | MG | FILM-COATED TABLET | /cycle | ||||
| 124574472 | 12457447 | 2 | SS | LEFLUNOMIDE. | LEFLUNOMIDE | 1 | Oral | U | UNKNOWN | 20905 | FILM-COATED TABLET | ||||||||
| 124574472 | 12457447 | 3 | SS | ENBREL | ETANERCEPT | 1 | Subcutaneous | Y | L76737 | 0 | 50 | MG | SOLUTION FOR INJECTION | /wk | |||||
| 124574472 | 12457447 | 4 | SS | ENBREL | ETANERCEPT | 1 | Subcutaneous | Y | M72573 | 0 | 50 | MG | SOLUTION FOR INJECTION | /wk | |||||
| 124574472 | 12457447 | 5 | C | ADCAL | CALCIUM CARBONATE | 1 | Unknown | 0 | |||||||||||
| 124574472 | 12457447 | 6 | C | CANDESARTAN | CANDESARTAN | 1 | Unknown | 0 | |||||||||||
| 124574472 | 12457447 | 7 | C | CELEBREX | CELECOXIB | 1 | Unknown | 0 | |||||||||||
| 124574472 | 12457447 | 8 | C | DOXAZOSIN | DOXAZOSINDOXAZOSIN MESYLATE | 1 | Unknown | 0 | |||||||||||
| 124574472 | 12457447 | 9 | C | LANSOPRAZOLE. | LANSOPRAZOLE | 1 | Unknown | 0 | |||||||||||
| 124574472 | 12457447 | 10 | C | PREDNISOLONE. | PREDNISOLONE | 1 | Unknown | 0 | 4 | MG | QD | ||||||||
| 124574472 | 12457447 | 11 | C | TOLTERODINE | TOLTERODINE | 1 | Unknown | 0 | 4 | MG | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124574472 | 12457447 | 1 | Rheumatoid arthritis |
| 124574472 | 12457447 | 2 | Rheumatoid arthritis |
| 124574472 | 12457447 | 3 | Rheumatoid arthritis |
| 124574472 | 12457447 | 4 | Rheumatoid arthritis |
| 124574472 | 12457447 | 5 | Osteopenia |
| 124574472 | 12457447 | 6 | Hypertension |
| 124574472 | 12457447 | 7 | Rheumatoid arthritis |
| 124574472 | 12457447 | 8 | Hypertension |
| 124574472 | 12457447 | 9 | Prophylaxis against gastrointestinal ulcer |
| 124574472 | 12457447 | 10 | Rheumatoid arthritis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124574472 | 12457447 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124574472 | 12457447 | Anxiety | |
| 124574472 | 12457447 | Blood pressure increased | |
| 124574472 | 12457447 | Cardiac failure | |
| 124574472 | 12457447 | Diarrhoea | |
| 124574472 | 12457447 | Heart rate irregular | |
| 124574472 | 12457447 | Joint dislocation | |
| 124574472 | 12457447 | Osteoarthritis | |
| 124574472 | 12457447 | Pain | |
| 124574472 | 12457447 | Palpitations | |
| 124574472 | 12457447 | Rash | |
| 124574472 | 12457447 | Rheumatoid arthritis | |
| 124574472 | 12457447 | 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 |
|---|---|---|---|---|---|---|
| 124574472 | 12457447 | 1 | 20141210 | 0 | ||
| 124574472 | 12457447 | 3 | 20150602 | 20160204 | 0 | |
| 124574472 | 12457447 | 4 | 20150602 | 20160204 | 0 | |
| 124574472 | 12457447 | 5 | 2010 | 0 | ||
| 124574472 | 12457447 | 6 | 2010 | 0 | ||
| 124574472 | 12457447 | 7 | 1996 | 0 | ||
| 124574472 | 12457447 | 8 | 2011 | 0 | ||
| 124574472 | 12457447 | 9 | 2000 | 0 | ||
| 124574472 | 12457447 | 10 | 199609 | 0 |