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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124664423 | 12466442 | 3 | F | 2014 | 20160711 | 20160615 | 20160718 | EXP | FR-UCBSA-2016021818 | UCB | 42.55 | YR | F | Y | 106.00000 | KG | 20160718 | MD | FR | FR |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124664423 | 12466442 | 1 | PS | CIMZIA | CERTOLIZUMAB PEGOL | 1 | Subcutaneous | 200 MG, EV 15 DAYS | Y | U | 125160 | 200 | MG | SOLUTION FOR INJECTION | |||||
| 124664423 | 12466442 | 2 | SS | CIMZIA | CERTOLIZUMAB PEGOL | 1 | Y | U | 125160 | SOLUTION FOR INJECTION | |||||||||
| 124664423 | 12466442 | 3 | C | Aprovel | IRBESARTAN | 1 | Oral | 75 | U | 0 | |||||||||
| 124664423 | 12466442 | 4 | C | Pantoprazole | PANTOPRAZOLE SODIUM | 1 | UNK | U | 0 | ||||||||||
| 124664423 | 12466442 | 5 | C | Imurel | AZATHIOPRINE SODIUM | 1 | Oral | 50 4 TIMES | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124664423 | 12466442 | 1 | Rheumatoid arthritis |
| 124664423 | 12466442 | 2 | Crohn's disease |
| 124664423 | 12466442 | 3 | Hypertension |
| 124664423 | 12466442 | 4 | Gastritis |
| 124664423 | 12466442 | 5 | Crohn's disease |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124664423 | 12466442 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124664423 | 12466442 | Alopecia | |
| 124664423 | 12466442 | Burning sensation | |
| 124664423 | 12466442 | Dizziness | |
| 124664423 | 12466442 | Gastritis | |
| 124664423 | 12466442 | Off label use | |
| 124664423 | 12466442 | Paraesthesia | |
| 124664423 | 12466442 | Skin lesion | |
| 124664423 | 12466442 | Weight decreased |
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 |
|---|---|---|---|---|---|---|
| 124664423 | 12466442 | 1 | 20140227 | 20160517 | 0 | |
| 124664423 | 12466442 | 3 | 20140601 | 0 | ||
| 124664423 | 12466442 | 5 | 201303 | 0 |