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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
125373451 | 12537345 | 1 | I | 20160621 | 20160707 | 20160707 | PER | US-TAKEDA-2016TUS011385 | TAKEDA | 40.00 | YR | F | Y | 0.00000 | 20160707 | 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
125373451 | 12537345 | 1 | PS | ENTYVIO | VEDOLIZUMAB | 1 | Intravenous (not otherwise specified) | UNK | U | 125476 | INFUSION | ||||||||
125373451 | 12537345 | 2 | SS | PREDNISONE. | PREDNISONE | 1 | Unknown | 30 MG, UNK | U | 0 | 30 | MG | |||||||
125373451 | 12537345 | 3 | C | IMURAN | AZATHIOPRINE | 1 | 100 MG, UNK | U | 0 | 100 | MG |
Indications of drugs used
Event ID | CASEID | INDI DRUG SEQ | INDI PT |
---|---|---|---|
125373451 | 12537345 | 1 | Crohn's disease |
125373451 | 12537345 | 2 | Product used for unknown indication |
Outcome of event
no results found |
Reactions reported
Event ID | CASEID | DRUG REC ACT | PT |
---|---|---|---|
125373451 | 12537345 | Abdominal distension | |
125373451 | 12537345 | Abdominal pain | |
125373451 | 12537345 | Back pain | |
125373451 | 12537345 | Balance disorder | |
125373451 | 12537345 | Feeling abnormal | |
125373451 | 12537345 | Flatulence | |
125373451 | 12537345 | Mood swings | |
125373451 | 12537345 | Pyrexia |
Reporting Sources (this data is often not reported and may therefore be missing here)
no results found |
Therapies reported
no results found |