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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127405851 | 12740585 | 1 | I | 2016 | 20160906 | 20160914 | 20160914 | EXP | US-UCBSA-2016035049 | UCB | 0.00 | M | Y | 0.00000 | 20160914 | CN | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127405851 | 12740585 | 1 | PS | Certolizumab pegol | CERTOLIZUMAB PEGOL | 1 | 400 MG, EV 2 WEEKS(QOW) (NDC- 5047470062) | 125160 | 400 | MG | QOW | ||||||||
| 127405851 | 12740585 | 2 | SS | CIMZIA | CERTOLIZUMAB PEGOL | 1 | 400 MG, EV 2 WEEKS(QOW) | 125160 | 400 | MG | POWDER AND SOLVENT FOR SOLUTION FOR INJECTION | QOW |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127405851 | 12740585 | 1 | Rheumatoid arthritis |
| 127405851 | 12740585 | 2 | Rheumatoid arthritis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127405851 | 12740585 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127405851 | 12740585 | Asthenia | |
| 127405851 | 12740585 | Drug dose omission | |
| 127405851 | 12740585 | Fatigue | |
| 127405851 | 12740585 | Fluid retention |
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 |
|---|---|---|---|---|---|---|
| 127405851 | 12740585 | 1 | 201607 | 201607 | 0 | |
| 127405851 | 12740585 | 2 | 2016 | 0 |