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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123412753 | 12341275 | 3 | F | 2016 | 20160824 | 20160506 | 20160831 | EXP | US-UCBSA-2016014495 | UCB | 59.64 | YR | M | Y | 102.00000 | KG | 20160831 | CN | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123412753 | 12341275 | 1 | PS | CIMZIA | CERTOLIZUMAB PEGOL | 1 | Subcutaneous | 400 MG, EV 2 WEEKS(QOW) | 125160 | 400 | MG | POWDER AND SOLVENT FOR SOLUTION FOR INJECTION | QOW | ||||||
| 123412753 | 12341275 | 2 | C | METHOTREXATE. | METHOTREXATE | 1 | Oral | 15 MG, WEEKLY (QW) | U | 0 | 15 | MG | /wk | ||||||
| 123412753 | 12341275 | 3 | C | MEDROL | METHYLPREDNISOLONE | 1 | UNK | 0 | |||||||||||
| 123412753 | 12341275 | 4 | C | MEDROL | METHYLPREDNISOLONE | 1 | Oral | 5 MG, ONCE DAILY (QD) | 0 | 5 | MG | QD | |||||||
| 123412753 | 12341275 | 5 | C | PREDNISONE. | PREDNISONE | 1 | UNK | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 123412753 | 12341275 | 1 | Rheumatoid arthritis |
| 123412753 | 12341275 | 2 | Rheumatoid arthritis |
| 123412753 | 12341275 | 3 | Rheumatoid arthritis |
| 123412753 | 12341275 | 5 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 123412753 | 12341275 | HO |
| 123412753 | 12341275 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 123412753 | 12341275 | Abasia | |
| 123412753 | 12341275 | Arthritis | |
| 123412753 | 12341275 | Fatigue | |
| 123412753 | 12341275 | Haemorrhage | |
| 123412753 | 12341275 | Infection | |
| 123412753 | 12341275 | Joint swelling | |
| 123412753 | 12341275 | Pain | |
| 123412753 | 12341275 | Pyrexia | |
| 123412753 | 12341275 | Rheumatoid arthritis |
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 |
|---|---|---|---|---|---|---|
| 123412753 | 12341275 | 1 | 201602 | 2016 | 0 | |
| 123412753 | 12341275 | 2 | 2013 | 0 | ||
| 123412753 | 12341275 | 4 | 20160410 | 0 |