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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124554253 | 12455425 | 3 | F | 201506 | 20160627 | 20160610 | 20160708 | EXP | GB-AMGEN-GBRSP2015121955 | AMGEN | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124554253 | 12455425 | 1 | PS | ENBREL | ETANERCEPT | 1 | Subcutaneous | 50 MG, WEEKLY | Y | 103795 | 50 | MG | SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE | /wk | |||||
| 124554253 | 12455425 | 2 | SS | LEFLUNOMIDE. | LEFLUNOMIDE | 1 | Oral | 10 MG (ON MONDAYS, WEDNESDAYS AND FRIDAYS) | 0 | 10 | MG | ||||||||
| 124554253 | 12455425 | 3 | SS | LEFLUNOMIDE. | LEFLUNOMIDE | 1 | Unknown | UNK(FOUR TIMES A WEEK) | 0 | ||||||||||
| 124554253 | 12455425 | 4 | SS | LEFLUNOMIDE. | LEFLUNOMIDE | 1 | Oral | FOUR TIMES A WEEK | 0 | ||||||||||
| 124554253 | 12455425 | 5 | C | PREDNISOLONE. | PREDNISOLONE | 1 | 4 MG, DAILY | 0 | 4 | MG | |||||||||
| 124554253 | 12455425 | 6 | C | CELEBREX | CELECOXIB | 1 | 100 MG, TWICE DAILY | 0 | 100 | MG | BID | ||||||||
| 124554253 | 12455425 | 7 | C | ADCAL /00056901/ | CARBAZOCHROME | 1 | UNK | 0 | |||||||||||
| 124554253 | 12455425 | 8 | C | CANDESARTAN | CANDESARTAN | 1 | UNK | 0 | |||||||||||
| 124554253 | 12455425 | 9 | C | DOXAZOSIN | DOXAZOSINDOXAZOSIN MESYLATE | 1 | UNK | 0 | |||||||||||
| 124554253 | 12455425 | 10 | C | LANSOPRAZOLE. | LANSOPRAZOLE | 1 | UNK | 0 | |||||||||||
| 124554253 | 12455425 | 11 | C | TOLTERODINE | TOLTERODINE | 1 | 4 MG, DAILY | 0 | 4 | MG | |||||||||
| 124554253 | 12455425 | 12 | C | TOLTERODINE | TOLTERODINE | 1 | 4 MG, DAILY | 0 | 4 | MG | |||||||||
| 124554253 | 12455425 | 13 | C | TOLTERODINE | TOLTERODINE | 1 | 4 MG, DAILY | 0 | 4 | MG | |||||||||
| 124554253 | 12455425 | 14 | C | TOLTERODINE | TOLTERODINE | 1 | 4 MG, DAILY | 0 | 4 | MG | |||||||||
| 124554253 | 12455425 | 15 | C | TOLTERODINE | TOLTERODINE | 1 | 4 MG, DAILY | 0 | 4 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124554253 | 12455425 | 1 | Rheumatoid arthritis |
| 124554253 | 12455425 | 2 | Rheumatoid arthritis |
| 124554253 | 12455425 | 5 | Rheumatoid arthritis |
| 124554253 | 12455425 | 6 | Rheumatoid arthritis |
| 124554253 | 12455425 | 7 | Osteopenia |
| 124554253 | 12455425 | 8 | Hypertension |
| 124554253 | 12455425 | 9 | Hypertension |
| 124554253 | 12455425 | 10 | Prophylaxis against gastrointestinal ulcer |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124554253 | 12455425 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124554253 | 12455425 | Anxiety | |
| 124554253 | 12455425 | Atrial fibrillation | |
| 124554253 | 12455425 | Blood pressure increased | |
| 124554253 | 12455425 | Cardiac failure | |
| 124554253 | 12455425 | Condition aggravated | |
| 124554253 | 12455425 | Diarrhoea | |
| 124554253 | 12455425 | Heart rate irregular | |
| 124554253 | 12455425 | Injection site rash | |
| 124554253 | 12455425 | Joint dislocation | |
| 124554253 | 12455425 | Osteoarthritis | |
| 124554253 | 12455425 | Pain | |
| 124554253 | 12455425 | Palpitations | |
| 124554253 | 12455425 | Rash | |
| 124554253 | 12455425 | Rheumatoid arthritis | |
| 124554253 | 12455425 | 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 |
|---|---|---|---|---|---|---|
| 124554253 | 12455425 | 1 | 20150602 | 20160204 | 0 | |
| 124554253 | 12455425 | 2 | 20141210 | 0 | ||
| 124554253 | 12455425 | 5 | 199609 | 0 | ||
| 124554253 | 12455425 | 6 | 1996 | 0 | ||
| 124554253 | 12455425 | 7 | 2010 | 0 | ||
| 124554253 | 12455425 | 8 | 2010 | 0 | ||
| 124554253 | 12455425 | 9 | 2011 | 0 | ||
| 124554253 | 12455425 | 10 | 2000 | 0 |