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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 122991232 | 12299123 | 2 | F | 20160818 | 20160425 | 20160826 | EXP | CA-UCBSA-2016014189 | UCB | 0.00 | A | F | Y | 0.00000 | 20160826 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 122991232 | 12299123 | 1 | PS | CIMZIA | CERTOLIZUMAB PEGOL | 1 | 200MG/ML | U | 125160 | SOLUTION FOR INJECTION | |||||||||
| 122991232 | 12299123 | 2 | C | ARAVA | LEFLUNOMIDE | 1 | UNK | U | 0 | ||||||||||
| 122991232 | 12299123 | 3 | C | CELEBREX | CELECOXIB | 1 | Oral | UNK, ONCE DAILY (QD) | U | 0 | QD | ||||||||
| 122991232 | 12299123 | 4 | C | HUMIRA | ADALIMUMAB | 1 | UNK | U | 0 | ||||||||||
| 122991232 | 12299123 | 5 | C | PREDNISONE. | PREDNISONE | 1 | UNK | U | 0 | ||||||||||
| 122991232 | 12299123 | 6 | C | LEFLUNOMIDE. | LEFLUNOMIDE | 1 | Oral | 20 MG, ONCE DAILY (QD) | U | 0 | 20 | MG | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 122991232 | 12299123 | 1 | Rheumatoid arthritis |
| 122991232 | 12299123 | 2 | Product used for unknown indication |
| 122991232 | 12299123 | 3 | Product used for unknown indication |
| 122991232 | 12299123 | 4 | Product used for unknown indication |
| 122991232 | 12299123 | 5 | Crohn's disease |
| 122991232 | 12299123 | 6 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 122991232 | 12299123 | HO |
| 122991232 | 12299123 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 122991232 | 12299123 | Drug ineffective | |
| 122991232 | 12299123 | Systemic lupus erythematosus |
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 |
|---|---|---|---|---|---|---|
| 122991232 | 12299123 | 1 | 20131107 | 20141107 | 0 | |
| 122991232 | 12299123 | 2 | 20160324 | 0 | ||
| 122991232 | 12299123 | 4 | 20121127 | 20131127 | 0 | |
| 122991232 | 12299123 | 6 | 20121129 | 20150625 | 0 |