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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
127539742 | 12753974 | 2 | F | 2016 | 20160912 | 20160915 | 20160919 | EXP | US-UCBSA-2016027124 | UCB | 25.12 | YR | F | Y | 67.00000 | KG | 20160919 | 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
127539742 | 12753974 | 1 | PS | Certolizumab pegol | CERTOLIZUMAB PEGOL | 1 | Subcutaneous | 400 MG, EV 4 WEEKS | 125160 | 400 | MG | ||||||||
127539742 | 12753974 | 2 | SS | FLAGYL | METRONIDAZOLEMETRONIDAZOLE HYDROCHLORIDE | 1 | UNK | Y | U | 0 | |||||||||
127539742 | 12753974 | 3 | C | Multivitamins | VITAMINS | 1 | UNK | U | 0 |
Indications of drugs used
Event ID | CASEID | INDI DRUG SEQ | INDI PT |
---|---|---|---|
127539742 | 12753974 | 1 | Crohn's disease |
127539742 | 12753974 | 2 | Product used for unknown indication |
127539742 | 12753974 | 3 | Product used for unknown indication |
Outcome of event
Event ID | CASEID | OUTC COD |
---|---|---|
127539742 | 12753974 | OT |
Reactions reported
Event ID | CASEID | DRUG REC ACT | PT |
---|---|---|---|
127539742 | 12753974 | Clostridium difficile infection | |
127539742 | 12753974 | Crohn's disease | |
127539742 | 12753974 | Diarrhoea | |
127539742 | 12753974 | Fatigue | |
127539742 | 12753974 | Flank pain | |
127539742 | 12753974 | Injection site discolouration | |
127539742 | 12753974 | Malaise | |
127539742 | 12753974 | Oropharyngeal pain |
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 |
---|---|---|---|---|---|---|
127539742 | 12753974 | 1 | 20160614 | 0 | ||
127539742 | 12753974 | 2 | 201608 | 201608 | 0 |