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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 81354872 | 8135487 | 2 | F | 20110211 | 20110902 | 20110914 | 20160901 | EXP | CA-UCBSA-028380 | UCB | 30.20 | YR | F | Y | 61.23000 | KG | 20160901 | MD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 81354872 | 8135487 | 1 | PS | CIMZIA | CERTOLIZUMAB PEGOL | 1 | Subcutaneous | 400 MG, EV 2 WEEKS(QOW) | Y | 55549 | 125160 | 400 | MG | SOLUTION FOR INJECTION | QOW | ||||
| 81354872 | 8135487 | 2 | SS | CIMZIA | CERTOLIZUMAB PEGOL | 1 | 200 MG, UNK | Y | 125160 | 200 | MG | SOLUTION FOR INJECTION | |||||||
| 81354872 | 8135487 | 3 | SS | CIMZIA | CERTOLIZUMAB PEGOL | 1 | 200 MG, UNK | Y | 125160 | 200 | MG | SOLUTION FOR INJECTION | |||||||
| 81354872 | 8135487 | 4 | C | PRENATAL VITAMINS | VITAMINS | 1 | Oral | UNK UNK, ONCE DAILY (QD) | 0 | QD | |||||||||
| 81354872 | 8135487 | 5 | C | Asaphen | ASPIRIN | 1 | Oral | 80 MG, ONCE DAILY (QD) | 0 | 80 | MG | QD | |||||||
| 81354872 | 8135487 | 6 | C | PREDNISONE. | PREDNISONE | 1 | Oral | VARIABLE (5-20) MG | 0 | QD | |||||||||
| 81354872 | 8135487 | 7 | C | PREDNISONE. | PREDNISONE | 1 | UNK, 20 MG | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 81354872 | 8135487 | 1 | Rheumatoid arthritis |
| 81354872 | 8135487 | 4 | Pregnancy |
| 81354872 | 8135487 | 5 | Product used for unknown indication |
| 81354872 | 8135487 | 6 | Rheumatoid arthritis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 81354872 | 8135487 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 81354872 | 8135487 | Arthralgia | |
| 81354872 | 8135487 | Exposure during pregnancy | |
| 81354872 | 8135487 | Gait disturbance | |
| 81354872 | 8135487 | Inappropriate schedule of drug administration | |
| 81354872 | 8135487 | Joint effusion | |
| 81354872 | 8135487 | Palpitations |
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 |
|---|---|---|---|---|---|---|
| 81354872 | 8135487 | 1 | 20110211 | 201103 | 0 | |
| 81354872 | 8135487 | 2 | 20110421 | 20110818 | 0 | |
| 81354872 | 8135487 | 3 | 20110825 | 20110825 | 0 | |
| 81354872 | 8135487 | 4 | 201012 | 0 | ||
| 81354872 | 8135487 | 6 | 20110215 | 2011 | 0 | |
| 81354872 | 8135487 | 7 | 2011 | 0 |