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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127589641 | 12758964 | 1 | I | 201010 | 20160912 | 20160919 | 20160919 | EXP | US-UCBSA-2016035205 | UCB | 38.00 | YR | F | Y | 0.00000 | 20160919 | PH | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127589641 | 12758964 | 1 | PS | CIMZIA | CERTOLIZUMAB PEGOL | 1 | Subcutaneous | 400 MG, EV 4 WEEKS (STRENGTH: 200MG) | U | 125160 | 400 | MG | |||||||
| 127589641 | 12758964 | 2 | SS | CIMZIA | CERTOLIZUMAB PEGOL | 1 | U | 125160 | |||||||||||
| 127589641 | 12758964 | 3 | C | REMICADE | INFLIXIMAB | 1 | UNK | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127589641 | 12758964 | 1 | Malaise |
| 127589641 | 12758964 | 2 | Crohn's disease |
| 127589641 | 12758964 | 3 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127589641 | 12758964 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127589641 | 12758964 | Abscess | |
| 127589641 | 12758964 | Malaise | |
| 127589641 | 12758964 | 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 |
|---|---|---|---|---|---|---|
| 127589641 | 12758964 | 1 | 201010 | 0 |