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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123835424 | 12383542 | 4 | F | 20160412 | 20160801 | 20160518 | 20160808 | EXP | US-UCBSA-2016017997 | UCB | 45.18 | YR | M | Y | 0.00000 | 20160808 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123835424 | 12383542 | 1 | PS | CIMZIA | CERTOLIZUMAB PEGOL | 1 | Subcutaneous | 200 MG, EV 2 WEEKS(QOW), #NDC 50474-0710-79 | Y | U | 901706 | 125160 | 200 | MG | SOLUTION FOR INJECTION | QOW | |||
| 123835424 | 12383542 | 2 | C | GABAPENTIN. | GABAPENTIN | 1 | 600MG | U | 0 | ||||||||||
| 123835424 | 12383542 | 3 | C | Ondansetron | ONDANSETRON | 1 | 4MG | U | 0 | ||||||||||
| 123835424 | 12383542 | 4 | C | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHENHYDROCODONE BITARTRATE | 1 | 7.5-325 | U | 0 | ||||||||||
| 123835424 | 12383542 | 5 | C | METHOTREXATE. | METHOTREXATE | 1 | 25MG | U | 0 | ||||||||||
| 123835424 | 12383542 | 6 | C | LIDOCAINE. | LIDOCAINE | 1 | 5 G | U | 0 | OINTMENT | |||||||||
| 123835424 | 12383542 | 7 | C | MELOXICAM. | MELOXICAM | 1 | 7.5/5ML | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 123835424 | 12383542 | 1 | Crohn's disease |
| 123835424 | 12383542 | 2 | Product used for unknown indication |
| 123835424 | 12383542 | 3 | Product used for unknown indication |
| 123835424 | 12383542 | 4 | Product used for unknown indication |
| 123835424 | 12383542 | 5 | Product used for unknown indication |
| 123835424 | 12383542 | 6 | Product used for unknown indication |
| 123835424 | 12383542 | 7 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 123835424 | 12383542 | HO |
| 123835424 | 12383542 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 123835424 | 12383542 | Drug dose omission | |
| 123835424 | 12383542 | Infection | |
| 123835424 | 12383542 | Oesophageal candidiasis |
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 |
|---|---|---|---|---|---|---|
| 123835424 | 12383542 | 1 | 20160205 | 2016 | 0 |