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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123499492 | 12349949 | 2 | F | 20141128 | 20160825 | 20160510 | 20160901 | EXP | CA-UCBSA-2016016521 | UCB | 66.62 | YR | M | Y | 93.00000 | KG | 20160901 | CN | CA | CA |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123499492 | 12349949 | 1 | PS | Certolizumab pegol ASp | CERTOLIZUMAB PEGOL | 1 | Subcutaneous | 400 MG, EV 2 WEEKS(QOW)X 3 | U | 125160 | 400 | MG | QOW | ||||||
| 123499492 | 12349949 | 2 | SS | Certolizumab pegol ASp | CERTOLIZUMAB PEGOL | 1 | Subcutaneous | 200 MG, EV 2 WEEKS(QOW) | U | 125160 | 200 | MG | QOW | ||||||
| 123499492 | 12349949 | 3 | SS | Certolizumab pegol ASp | CERTOLIZUMAB PEGOL | 1 | UNK | U | 125160 | ||||||||||
| 123499492 | 12349949 | 4 | SS | Certolizumab pegol ASp | CERTOLIZUMAB PEGOL | 1 | Subcutaneous | 200 MG, EV 2 WEEKS(QOW) | U | 125160 | 200 | MG | QOW | ||||||
| 123499492 | 12349949 | 5 | SS | Certolizumab pegol ASp | CERTOLIZUMAB PEGOL | 1 | Subcutaneous | 200 MG, EV 3 WEEKS | U | 125160 | 200 | MG | Q3W | ||||||
| 123499492 | 12349949 | 6 | SS | Certolizumab pegol ASp | CERTOLIZUMAB PEGOL | 1 | Subcutaneous | 200 MG, EV 2 WEEKS(QOW) | U | 125160 | 200 | MG | QOW | ||||||
| 123499492 | 12349949 | 7 | SS | PREDNISONE. | PREDNISONE | 1 | Y | U | 0 | DROP |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 123499492 | 12349949 | 1 | Ankylosing spondylitis |
| 123499492 | 12349949 | 2 | Off label use |
| 123499492 | 12349949 | 3 | Crohn's disease |
| 123499492 | 12349949 | 7 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 123499492 | 12349949 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 123499492 | 12349949 | Cataract | |
| 123499492 | 12349949 | Crohn's disease | |
| 123499492 | 12349949 | Inappropriate schedule of drug administration | |
| 123499492 | 12349949 | Off label use |
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 |
|---|---|---|---|---|---|---|
| 123499492 | 12349949 | 1 | 20141128 | 0 | ||
| 123499492 | 12349949 | 5 | 2015 | 2016 | 0 | |
| 123499492 | 12349949 | 6 | 201603 | 0 |