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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125688861 | 12568886 | 1 | I | 201606 | 20160712 | 20160719 | 20160719 | EXP | FR-UCBSA-2016026259 | UCB | 56.19 | YR | F | Y | 0.00000 | 20160719 | OT | FR | FR |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125688861 | 12568886 | 1 | PS | CIMZIA | CERTOLIZUMAB PEGOL | 1 | Subcutaneous | 400 MG, UNK | Y | U | 125160 | 400 | MG | SOLUTION FOR INJECTION | |||||
| 125688861 | 12568886 | 2 | C | SIMPONI | GOLIMUMAB | 1 | UNK | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125688861 | 12568886 | 1 | Psoriatic arthropathy |
| 125688861 | 12568886 | 2 | Psoriatic arthropathy |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125688861 | 12568886 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125688861 | 12568886 | Decreased appetite | |
| 125688861 | 12568886 | Diarrhoea | |
| 125688861 | 12568886 | Face oedema | |
| 125688861 | 12568886 | Hyperthermia | |
| 125688861 | 12568886 | Pruritus | |
| 125688861 | 12568886 | Rash |
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 |
|---|---|---|---|---|---|---|
| 125688861 | 12568886 | 1 | 20160603 | 20160603 | 0 | |
| 125688861 | 12568886 | 2 | 201405 | 201605 | 0 |