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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126775922 | 12677592 | 2 | F | 20160812 | 20160823 | 20160823 | 20160830 | EXP | US-TAKEDA-2016TUS014791 | TAKEDA | 67.41 | YR | F | Y | 81.63000 | KG | 20160830 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126775922 | 12677592 | 1 | SS | Vedolizumab | VEDOLIZUMAB | 1 | Intravenous (not otherwise specified) | 300 MG, UNK | 0 | 300 | MG | POWDER FOR SOLUTION FOR INFUSION | |||||||
| 126775922 | 12677592 | 2 | PS | ACTOS | PIOGLITAZONE HYDROCHLORIDE | 1 | Oral | 30 MG, QD | 21073 | 30 | MG | TABLET | QD | ||||||
| 126775922 | 12677592 | 3 | SS | PREDNISONE. | PREDNISONE | 1 | Oral | 20 MG, QD | 0 | 20 | MG | TABLET | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126775922 | 12677592 | 1 | Crohn's disease |
| 126775922 | 12677592 | 2 | Diabetes mellitus |
| 126775922 | 12677592 | 3 | Crohn's disease |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126775922 | 12677592 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126775922 | 12677592 | Blood glucose increased | |
| 126775922 | 12677592 | Tremor | |
| 126775922 | 12677592 | Vision blurred |
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 |
|---|---|---|---|---|---|---|
| 126775922 | 12677592 | 1 | 20160815 | 0 | ||
| 126775922 | 12677592 | 2 | 2008 | 0 | ||
| 126775922 | 12677592 | 3 | 201607 | 0 |