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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124982472 | 12498247 | 2 | F | 20131004 | 20160627 | 20160627 | 20160701 | EXP | MX-UCBSA-2016023532 | UCB | 57.31 | YR | M | Y | 0.00000 | 20160701 | MD | MX | MX |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124982472 | 12498247 | 1 | PS | CIMZIA | CERTOLIZUMAB PEGOL | 1 | Subcutaneous | 400 MG, MONTHLY (QM) | N | U | 125160 | 400 | MG | SOLUTION FOR INJECTION | /month | ||||
| 124982472 | 12498247 | 2 | SS | CIMZIA | CERTOLIZUMAB PEGOL | 1 | N | U | 125160 | SOLUTION FOR INJECTION | |||||||||
| 124982472 | 12498247 | 3 | C | IRBESARTAN. | IRBESARTAN | 1 | UNK | U | 0 | ||||||||||
| 124982472 | 12498247 | 4 | C | SULFASALAZINE. | SULFASALAZINE | 1 | 500 MG, 3X/DAY (TID) | U | 0 | 500 | MG | TID | |||||||
| 124982472 | 12498247 | 5 | C | Calcort | DEFLAZACORT | 1 | 18 MG, ONCE DAILY (QD) | U | 0 | 18 | MG | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124982472 | 12498247 | 1 | Ankylosing spondylitis |
| 124982472 | 12498247 | 2 | Off label use |
| 124982472 | 12498247 | 3 | Hypertension |
| 124982472 | 12498247 | 4 | Immunosuppression |
| 124982472 | 12498247 | 5 | Immunosuppression |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124982472 | 12498247 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124982472 | 12498247 | Off label use | |
| 124982472 | 12498247 | Tuberculosis |
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 |
|---|---|---|---|---|---|---|
| 124982472 | 12498247 | 1 | 20131004 | 20160520 | 0 | |
| 124982472 | 12498247 | 3 | 20130602 | 0 |